Survivorship Care Planning, Quality of Life, and Confidence to Transition to Survivorship: A Randomized Controlled Trial with Women Ending Treatment for Breast Cancer

Abstract

Purpose:

The Polaris Oncology Survivorship Transition (POST) system is a computer-based program that integrates information from the electronic health record, oncology team, and the patient to produce a personalized Survivorship Care Plan. The purpose of this study was to compare the POST to treatment as usual on confidence, quality of life, and interest in mental health referrals in women ending treatment for breast cancer.

Sample:

Two hundred women (100 POST, 100 treatment as usual) ending treatment for breast cancer were enrolled in a randomized controlled trial.

Design:

Women randomized to the POST condition received a personalized care plan during a baseline/intervention appointment. At enrollment and baseline/intervention, a number of outcomes were examined in this study, including confidence to enter survivorship measured by the Confidence in Survivorship Index (CSI) and Quality of Life (QOL). One, three, and six month follow up assessments were also conducted.

Findings:

Treatment groups did not differ in terms of QOL scores at any time points. Mean CSI scores were statistically different between POST and treatment as usual at baseline for the total CSI score and both subscales, but only for confidence in knowledge about prevention and treatment at the 1-month follow-up. All significant differences were in favor of the POST intervention as mean CSI scores were higher for participants who received the POST intervention as opposed to treatment as usual. These findings disappeared at the 3 and 6 month follow up assessments. Finally, patients who received the POST intervention were twice as likely to request mental health/social services referrals compared to women who received treatment as usual.

Implications:

Oncologists may use the POST to build personalized care plans for women ending treatment for cancer, which may enhance patients’ confidence in the short term as well as encourage use of mental health resources.

Introduction

In 2006, the Institute of Medicine published “From Cancer Patient to Cancer Survivor: Lost in Transition.”¹ This publication emphasized that cancer survivors were historically ignored in medical care and specifically noted that survivorship care plans should be carefully built for all patients ending treatment for cancer. The Institute of Medicine stated such plans should include four essential components of care: (1) Prevention of recurrent or new cancers and other late effects; (2) Surveillance for cancer spread and assessment of medical and psychosocial late effects; (3) Intervention for consequences of cancer and treatment that address psychosocial distress, sexual dysfunction, physical symptoms and disability, and financial concerns; and (4) Coordination between specialists and primary care providers.¹ This publication was received with interest as many providers acknowledged survivorship planning needed to be addressed. It was also received with skepticism because, at the time, there was a lack of evidence that survivorship planning would have a positive impact on survivors.

Since this seminal publication, the American College of Surgeons² implemented accreditation expectations for comprehensive cancer centers that requires all patients to receive written or electronic plans. These survivorship care plans should be: (1) prepared by oncology providers, (2) given to patients upon completion of treatment, and (3) include a record of care received, important disease characteristics, as well as a follow-up plan incorporating evidence-based standards.² Again, when this occurred in 2015, the oncology care communities responded with mixed reactions. Many providers voiced concerns regarding the feasibility of meeting such requirements without additional resources and, in addition to feasibility concerns, this was a new standard-of-care requirement that lacked clear evidence of bettering patient outcomes. These concerns were founded as many of the studies, published at the time, lacked appropriate methodology to draw definitive conclusions about the impact care plans would have on patient, provider, and healthcare systems outcomes.^3,4

However, many believed that survivorship plans could enhance patient outcomes such as QOL because they would provide a neglected ‘roadmap’ for navigating the physical, emotional, social, spiritual, and financial demands placed on new survivors. The care plans were also slated to contain important information about cancer treatment and diagnosis history. It follows that the Institute of Medicine, as well as many others, expected this increase in knowledge and a better ‘roadmaping’ would result in better outcomes for survivors in the short and long-term. These were hypotheses that warranted quality research. Fortunately, over the past few years, randomized controlled trials have appeared in the literature, examining the impact of survivorship care plans across various types of cancers on a range of outcomes. Unfortunately, the results of these studies appear to be inconsistent. Some randomized trials have resulted in positive outcomes for patients. Kvale et al. (2016)⁵ found that women ending treatment for breast cancer, who received a tailored care plan intervention, reported better quality of life (QOL), better health, and less role limitations, than women who did not receive the intervention. Jefford et al. (2016)⁶ published data that showed colorectal cancer patients had improved healthcare satisfaction ratings after receiving a care plan. Finally, Oleson et al. (2016)⁷ found better physical well-being and QOL at 9 months among gynecological cancer survivors, while Hershman et al. (2013)⁸ found less worry in survivors three months after receiving survivorship plans.

In contrast, some authors have published data from randomized trials showing a negative impact on cancer patients. De Rooij et al (2017, 2018)^9,10 found that ovarian cancer patients who received care plans felt less confident that their treatment would cure their disease and, in a sample of endometrial and ovarian cancer patients, that those who received plans reported greater symptoms and concerns about their illness. Finally, other researchers have recently published a lack of impact on patient outcomes including QOL,^6,7,10–12 cancer distress,^6,11 health care utilization,⁹ adherence to medical regimens,⁶ and satisfaction with health care.^8,9,11,14,15

The POST system is computerized program that combines information from oncology providers, patients, and electronic health records to generate personalized survivorship care plans that meet content set by the Institute of Medicine and American Cancer Society (see Appendix A). A Phase 1 grant from the National Cancer Institute supported the development of the POST program. This Phase 2 grant supported a randomized controlled trail that examined the impact of the POST survivorship care plans, as compared to treatment as usual, on various breast cancer survivors’ physical and psychosocial outcomes. The purpose of this paper is to present the results from the RCT that examined primary outcomes including QOL, confidence to transition to survivorship, and interest in mental health/social services referrals.

We hypothesized that women receiving the POST intervention would have better QOL, confidence, and interest in mental health referrals as opposed to women receiving treatment as usual. We expected this because the POST provides comprehensive, personalized information, feedback and referrals for women ending treatment for breast cancer, increasing their knowledge and resources related to survivorship.

Methods

Participants

Two hundred women ending treatment for breast cancer enrolled in this study. One hundred were randomized to receive the POST treatment and 100 were randomized to receive treatment as usual. Table 3 presents the demographic data of the sample and comparison of the two groups. The average age of women participating in the study was 60 years old with a standard deviation (SD) of 11. There was no statistically significant difference in age between the POST and treatment as usual groups. The majority of participants were white, non-Hispanic, had more than a high school education, were married, were diagnosed with breast cancer less than 9 months earlier, had stage I breast cancer, and were receiving radiation as treatment, with fewer women receiving chemotherapy. These characteristics were similar between the POST and treatment as usual groups (Table 1).

Table 3.

Demographics of POST-2 participants

Demographics		Total (n=200)		POST (n=100)		TREATMENT AS USUAL (n=100)
Continuous variables		Mean	SD	Mean	SD	Mean	SD	P-value
Age	Age	60	11	61	11	59	11	0.20
Categorical variables		n	Percent	n	Percent	n	Percent	P-value
Race/Ethnicity	White, non-Hispanic	163	86	85	89	78	84	0.55
	White, Hispanic	9	4.8	5	5.2	4	4.3
	Black/African American	10	5.3	3	3.1	7	7.5
	Other	7	3.7	3	3.1	4	4.3
Education	High school graduate/GED or less	36	18	15	15	21	21	0.70
	Some college or 2-year degree	64	32	34	34	30	30
	4-year college graduate or Associates degree	45	23	24	24	21	21
	More than 4-year college degree	54	27	27	27	27	27
Marital status	Married	115	58	53	53	62	62	0.25
	Not married	85	43	47	47	38	38
When diagnosed with breast cancer	6 months ago or less	125	63	59	59	66	66	0.67
	9 months ago	59	30	31	31	28	28
	12 months ago	10	5.0	6	6.0	4	4.0
	More than a year ago	6	3.0	4	4.0	2	2.0
Stage of breast cancer	0, ductal carcinoma in situ (DCIS)	22	11	9	9.0	13	13	0.82
	I	90	45	46	46	44	44
	II	55	28	26	26	29	29
	III	17	8.5	9	9.0	8	8.0
	IV, metastatic, advanced	1	0.50	1	1.0	0	0.0
	I don’t know	15	7.5	9	9.0	6	6.0
Treatment plan	Chemotherapy	9	4.5	2	2.0	7	7.0	0.21
	Radiation	163	82	85	85	78	78
	Surgery	28	14	13	13	15	15

Table 1.

Additional Selections Available to Include within the POST System

Side Effects	Informational Libraries
Anemia	Alcohol
Cardiac dysfunction	Anemia
Cellulitis	Anxiety*
Central venous catheter infection or clot	Appearance after treatment
Central venous catheter placement	Appetite changes
Decreased range of motion to affected arm/shoulder	Bleeding problems
Diarrhea/constipation	Breast reconstruction
Drug hypersensitivity	Constipation
DVT (blood clot)	Depression*
Febrile neutropenia	Diarrhea
GI (nausea, vomiting, diarrhea, mucositis)	Diet and nutrition*
Hospitalization during chemotherapy	Exercise and cancer*
Hot flashes or night sweats	Fatigue/lack of energy
Lymphedema	Fear of recurrence*
Mood disturbances	Finances/employment
Nail changes	Hair loss (alopecia)
Nausea/vomiting	Hot flashes and night sweats
Pain	Infertility and premature menopause
Peripheral neuropathy	Lymphedema
Premature menopause	Memory problems
Sexual problems or lack of interest in sex	Mouth and throat changes
Sleep difficulties	Nausea or vomiting
Swelling in arms or legs	Nerve changes
Tingling in hands or feet	Pain
Tiredness/fatigue	Relationship problems*
Trouble eating or swallowing	Relaxation techniques to cope with stress*
Unhappy with appearance due to cancer treatment	Religion/spirituality
Weight gain	Sexual problems*
Weight loss	Skin and nail changes
Vaginal dryness or pain during intercourse	Sleep problems
	Smoking*
	Social Support*
	Urination changes
	Weight grain*

^*indicates libraries that all POST patients receive regardless of whether the patient selected the library during the assessment.

Measures

A number of assessment tools were administered at each of the time points of the study (Table 2). These tools assessed various aspects of physical and emotional symptoms, as well as perceptions of quality of oncology care related to survivorship planning. For the purposes of this paper, we are only highlighting the assessments relevant to the present analyses.

Table 2.

Schedule and Order of Assessments

Measure	Construct Measured	Baseline Assessment		1M	3M	6M
		Enrollment Visit	Research Visit
POST Patient Assessment	Distress & symptoms, social support, physical functioning, alcohol use, tobacco use, barriers, referrals, SCP topics, unanswered questions about cancer, and SCP to PCP	√
Demographics and Cancer Related Information	Demographic Information	√
Satisfaction Survey of POST Assessment	Patient satisfaction of POST assessment	√
CSI	Confidence in Survivorship Information	√	√	√	√	√
PEPPI	Perceived Efficacy of Patient- Physician Interaction	√	√
City of Hope Quality of Life – Breast Cancer (QoL-BC)	Quality of Life	√		√	√	√
Survivorship Planning Content Checklist	Quality of patient-oncologist discussion topics		√
Health Behavior Questionnaire	Patient Health Behavior		√	√	√	√
PHQ2/GAD2	Depression /Anxiety	√ (part of POST Patient Assessment)		√	√	√
Satisfaction Survey of Survivorship Care Plan	Satisfaction of Survivorship Care Plan		√	√	√	√
Adherence Scale	Adherence to health appointment & scan recommendations					√
Cornell Index	Health Care Utilization			√	√	√
Chart Review	Essential Variables					√

Demographics and Cancer Related Information:

Patients completed an 8-item assessment that gathered demographic and cancer-related information. Participants were asked to indicate their age, ethnicity, race, marital status, education level, cancer stage, and date of diagnosis. The research team collected additional cancer-related information via patients’ medical charts, focusing on the details of the end of active treatment, survivorship care planning status, and ongoing therapy information.

POST Patient Assessment:

The POST Patient Assessment was created for the present study. All participants received this assessment during enrollment; however, the POST women were given a slightly more comprehensive version of the assessment. All patients received a 23-item assessment measuring distress, social support, physical symptoms, alcohol use, tobacco use, physical functioning, and a rating of how well the patient had been able to manage day-to-day life on a scale from “Very poorly” to “Very well”. The POST women received additional items on the need for referrals, interest in survivorship care plan library topics, barriers experienced, unanswered questions about their cancer diagnosis or care, and interest in sending a copy of their survivorship care plans to their primary care providers.

The City of Hope Quality of Life – Breast Cancer Version (QoL-BC):

Quality of life was assessed using the City of Hope Quality of Life – Breast Cancer Version (QoL-BC) at every follow-up time point.¹⁶ The assessment included 43-items measuring physical, psychological, social, and spiritual quality of life. Participants rated each item on a scale from 0–10 which “0” indicating worst outcome/experience and “10” indicating the best outcome/experience.

Confidence in Transitioning to Survivorship Questionnaire (CSI):

The Confidence in Transitioning to Survivorship Questionnaire (CSI) assessment was given to participants at every time point of the study to measure patient confidence, knowledge, and their preparedness for survivorship.¹⁷ The CSI contained 13 self-report questions in which patients rated their preparedness for survivorship, confidence in knowledge about prevention and side effects, prevention of recurrence, familial risk of cancer, and access to resources on a 3-point scale from “Not at all confident” to “Very confident”.

Chart Review:

Chart reviews were conducted by the research team 6 months after patients were enrolled in the study. A range of information was collected including demographic information (i.e. age, race, gender, ethnicity, zip code) and cancer-related information (i.e. diagnosis, date of diagnosis, cancer state, cancer site, type of treatment, and date of last treatment) and was entered into REDCap¹⁸, the affiliated hospital’s electronic data capture system. The researcher recorded whether a care plan visit was completed and whether a plan was received and reviewed at the visit. If a care plan was on the medical chart, a content checklist recorded the information in the plan. We also assessed if patients were given referrals to mental health services.

Procedures

Trial Design:

This study was an randomized controlled trial that investigated the impact of survivorship care planning on patient and provider outcomes. Two hundred breast cancer patients ending active treatment were randomized to either treatment as usual (n=100) or the POST intervention (n=100). Women were eligible to participate if they were <18 years of age, had a confirmed non-metastatic cancer diagnosis (stage I to III), had an active treatment plan, were alert and oriented, could read and comprehend English at a 6^th grade level, and were available for follow-up assessments. Participants were excluded from participation if they had: already received a care plan; visual impairments that prevented them from being able to read; lower than a 6^th grade reading level; a severe illness that would prevent communication with the study team; a mental illness that would impact their mental state (i.e. dementia, disorientation, delirium, or psychosis); no email or phone for follow up assessments.

All participants completed assessments at enrollment and post intervention, which was a research visit within one month of enrollment, and at 1, 3, and 6 months (Table 2). At the research visit, the POST group received the POST survivorship care plan intervention delivered by an oncology nurse practitioner who was part of the study staff. The participants had the opportunity to be compensated $80; participants were given a $20 gift card after the research visit and after each follow-up survey.

Recruitment and Consent:

There were several ways in which participants were identified: 1) identification through research assistants using a medical oncology provider schedule, 2) identification through RAs at the breast/cancer board conference, 3) direct recommendations from the oncology care team, 4) recommendations from radiation oncology nurses, 5) other direct recommendations from other members of the oncology team. Once potential participants were identified, the team collected information relevant to the inclusion/exclusion criteria. Eligible participants were approached at the end of their active treatment and if interested, participants completed the informed consent process. Active treatment was defined as the completion of the patients’ last care regimen including surgery, radiation, or adjuvant chemotherapy. Participants were done with active treatment even if they were receiving maintenance therapies (i.e. Anastrozole, Herceptin, etc.)

Intervention and Treatment as Usual:

POST Intervention.

Patients randomized to the intervention received the POST survivorship care plans at the baseline visit, before the administration of final baseline assessments. Prior to the research visit, the study nurse and the UMass research assistants contributed to the construction of the POST plans, guided by the patients’ responses to the POST assessment as well as their health records. Notably, the POST systems’ integration with the patients’ electronic health records abstracted and pre-populated some data into the patients’ care plans such as information about the patients’ demographics, diagnosis, care team, treatment, and upcoming schedule. Other data were entered manually into the POST system. The study nurse and research staff reviewed all pre-populated information to ensure accuracy.

The POST survivorship care plans consisted of 10 components: (1) demographic information, (2) diagnosis and status, (3) medical care team, (4) surgery and therapy details, (5) side effects (Table 1), (6) dates of recent tests, exams, and scans, (7) current medications, (8) barriers, (9) upcoming appointments and/or appointments that needed to be scheduled, and (10) libraries of information and references (Table 1). All plans contained standard sections, including a breast-cancer follow-up care plan, general recommendations for women recovering from breast cancer, possible late and long-term effects of cancer treatment, red flags to look for that indicate when to call your oncologist, and national cancer resources (See Appendix A). The study nurse reviewed all sections of the care plan in the POST intervention group, leaving time for questions and discussion. All patients received a hard copy of their plans, had a copy uploaded to their electronic health records, and had a copy sent to their primary care providers, for those who consented.

Women in the POST intervention group could also request a referral for a range of resources including mental health or social support services through the POST. If requested, the research team provided referrals.

Treatment as Usual.

The women randomized to receive treatment as usual received standard of care at the oncology center where the study was conducted. It is notable that when the grant was funded, standard of care was that most women ending treatment for breast cancer were not receiving care plans. This changed during the course of the study as the center implemented care planning for all patients coming through the program. While 30 women did not receive care plans, 70 women in the treatment as usual did receive the cancer center’s care plans, which was standard of care.

For those who received the standard of care, nurses created the care plans using the program Journey Forward (2007). The plans summarized patients’ treatment information, potential late effects, signs of recurrence, and tips for a healthy post-cancer lifestyle. The oncology staff manually entered the information for each survivorship care plan and used the Survivorship Care Plan Builder to create individualized care plans.¹⁹ Each plan was reviewed one-on-one with each patient.

Finally, the research staff worked closely with the oncology nurses who delivered the standard of care plans to ensure that the women in the treatment as usual did not receive any of the POST intervention.

Results and Discussion

Statistical Analysis Plan

Means and standard deviations were reported for continuous variables and differences in means were compared between the POST and treatment as usual groups using t-tests. Percentages were reported for categorical variables and Fisher’s exact test was used to test for differences between groups. An alpha level of 0.05 was used to determine statistical significance for all analyses. All analysis was conducted using SAS 9.4 (SAS Institute, Cary, NC, USA).

Treatment Group Differences

Quality of Life (QOL):

QoL measures were not statistically significantly different between POST and treatment as usual at any time point in the study (Table 4).

Table 4.

QOL measures by intervention group

		Total		POST		TREATMENT AS USUAL
		Mean	SD	Mean	SD	Mean	SD	P-value
Enrollment (n=200)	n			100		100
	QoL Overall	6.6	1.4	6.6	1.4	6.5	1.4	0.83
	QoL: Physical well being	7.5	1.6	7.6	1.5	7.4	1.6	0.29
	QoL: Psychological well being	6.3	1.8	6.3	1.7	6.3	1.8	0.96
	QoL: Social well being	7.0	1.7	7.0	1.6	7.0	1.8	0.99
	QoL: Spiritual well being	5.8	2.1	5.8	2.0	5.9	2.2	0.90
1-month follow-up (n=180)	n			86		94
	QoL Overall	6.4	1.4	6.6	1.4	6.2	1.4	0.08
	QoL: Physical well being	7.2	1.8	7.4	1.7	7.0	1.9	0.13
	QoL: Psychological well being	6.1	1.7	6.3	1.6	5.9	1.8	0.11
	QoL: Social well being	6.8	1.7	7.0	1.6	6.6	1.8	0.16
	QoL: Spiritual well being	6.0	2.1	6.0	2.1	5.9	2.1	0.66
3-month follow-up (n=178)				86		92
	QoL Overall	6.5	1.4	6.5	1.4	6.4	1.4	0.80
	QoL: Physical well being	7.2	1.9	7.4	1.8	7.0	1.9	0.14
	QoL: Psychological well being	6.2	1.7	6.1	1.7	6.2	1.7	0.74
	QoL: Social well being	7.0	1.7	7.1	1.7	7.0	1.7	0.73
	QoL: Spiritual well being	5.8	2.3	5.9	2.2	5.8	2.4	0.92
6-month follow-up (n=180)				85		95
	QoL Overall	6.5	1.4	6.5	1.4	6.5	1.4	0.97
	QoL: Physical well being	7.2	1.9	7.3	1.9	7.1	1.8	0.49
	QoL: Psychological well being	6.2	1.7	6.1	1.6	6.2	1.7	0.68
	QoL: Social well being	7.2	1.7	7.3	1.6	7.1	1.8	0.46
	QoL: Spiritual well being	5.9	2.2	5.8	2.1	5.9	2.2	0.77

Overall Confidence and 2 subscales:

As Figures 1 through 3 illustrate, there were no significant differences between POST and treatment as usual at enrollment with respect to mean CSI scores. Mean CSI scores were statistically different between POST and treatment as usual at baseline for the total CSI score and both subscales, but only for confidence in knowledge about prevention and treatment at the 1-month follow-up. All significant differences were in favor of the POST intervention as mean CSI scores were higher for participants who received the POST intervention as opposed to treatment as usual. These findings disappeared at the 3 and 6 month follow up assessments.

Figure 1.

Mean Overall CSI

Figure 3.

Mean confidence in knowledge of past cancer diagnosis and treatment

Individual Confidence Items:

We also looked at group differences in the individual items assessed by the CSI. As seen in Table 5, immediately after the intervention occurred (baseline), participants who received the POST had higher confidence scores, than treatment as usual, that they understood the type of cancer they were diagnosed with (p=0.02), treatments they had received (p=0.01), strategies for preventing (p=0.01) and treating (p=0.02) long term side effects. They also had significantly higher confidence that they understood the long-term emotional effects (p<0.001), as well as how to prevent (p=0.01) and treat (p=.001) long-term emotional effects. Finally, at baseline the POST patients reported higher confidence in knowing community resources available to them (p=0.01).

Table 5.

Detailed CSI responses at each point in the study period comparing POST and TREATMENT AS USUAL

		Total		POST		TREATMENT AS USUAL
		n	Percent	n	Percent	n	Percent	P-value
Enrollment (n=200)	n			100		100
	Type of cancer you have/had	165	83	81	81	84	84	0.71
	Stage of cancer you have/had	159	80	76	76	83	83	0.29
	Treatments you received/are receiving for cancer	169	85	85	85	84	84	0.99
	Things you can do to help prevent your cancer from recurring	86	43	43	43	43	43	0.99
	Long-term physical effects you may experience from cancer and its treatment	77	39	36	36	41	41	0.56
	Strategies for preventing long-term physical effects of cancer treatment	67	34	28	28	39	39	0.13
	Strategies for treating long-term physical effects of cancer treatment	73	37	35	35	38	38	0.77
	Long-term emotional effects you may experience from cancer and its treatment	76	38	39	39	37	37	0.88
	Preventing long-term emotional effects of cancer	75	38	38	38	37	37	0.99
	Strategies for treating long-term emotional effects of cancer treatment	74	37	37	37	37	37	0.99
	Community resources available to help with long-term effects of cancer and it	71	36	37	37	34	34	0.77
	Your family members are at increased risk for cancer	95	48	46	46	49	49	0.78
	Your family members can get information on their risk for cancer	97	49	49	49	48	48	0.99
Baseline (n=187)				90		97
	*Type of cancer you have/had	163	87	84	93	79	81	0.02
	*Stage of cancer you have/had	158	84	81	90	77	79	0.07
	*Treatments you received/are receiving for cancer	165	88	85	94	80	82	0.01
	Things you can do to help prevent your cancer from recurring	101	54	55	61	46	47	0.08
	Long-term physical effects you may experience from cancer and its treatment	102	55	56	62	46	47	0.06
	*Strategies for preventing long-term physical effects of cancer treatment	102	55	58	64	44	45	0.01
	Strategies for treating long-term physical effects of cancer treatment	97	52	55	61	42	43	0.02
	*Long-term emotional effects you may experience from cancer and its treatment	100	53	61	68	39	40	0.0002
	*Preventing long-term emotional effects of cancer	100	53	57	63	43	44	0.01
	*Strategies for treating long-term emotional effects of cancer treatment	105	56	62	69	43	44	0.001
	*Community resources available to help with long-term effects of cancer and it	94	50	55	61	39	40	0.01
	Your family members are at increased risk for cancer	98	52	50	56	48	49	0.46
	Your family members can get information on their risk for cancer	100	53	52	58	48	49	0.30
1-month follow-up (n=180)				86		94
	Type of cancer you have/had	134	74	63	73	71	76	0.74
	Stage of cancer you have/had	132	73	61	71	71	76	0.50
	Treatments you received/are receiving for cancer	146	81	69	80	77	82	0.85
	Things you can do to help prevent your cancer from recurring	75	42	37	43	38	40	0.76
	Long-term physical effects you may experience from cancer and its treatment	69	38	38	44	31	33	0.13
	Strategies for preventing long-term physical effects of cancer treatment	68	38	37	43	31	33	0.17
	Strategies for treating long-term physical effects of cancer treatment	64	36	31	36	33	35	0.99
	*Long-term emotional effects you may experience from cancer and its treatment	77	43	44	52	33	35	0.03
	*Preventing long-term emotional effects of cancer	78	44	43	51	35	37	0.10
	Strategies for treating long-term emotional effects of cancer treatment	80	45	43	51	37	39	0.14
	Community resources available to help with long-term effects of cancer and it	78	44	47	55	31	33	0.004
	Your family members are at increased risk for cancer	87	49	40	47	47	50	0.77
	Your family members can get information on their risk for cancer	95	53	46	54	49	52	0.88
3-month follow-up (n=178)				86		92
	Type of cancer you have/had	138	78	63	73	75	82	0.21
	Stage of cancer you have/had	145	81	68	79	77	84	0.45
	Treatments you received/are receiving for cancer	144	81	69	81	75	82	1.00
	Things you can do to help prevent your cancer from recurring	83	47	39	46	44	48	0.88
	Long-term physical effects you may experience from cancer and its treatment	72	41	34	40	38	42	0.88
	Strategies for preventing long-term physical effects of cancer treatment	73	41	34	40	39	42	0.76
	Strategies for treating long-term physical effects of cancer treatment	75	42	32	38	43	47	0.23
	Long-term emotional effects you may experience from cancer and its treatment	77	44	36	42	41	45	0.88
	Preventing long-term emotional effects of cancer	79	45	43	51	36	39	0.13
	Strategies for treating long-term emotional effects of cancer treatment	74	42	37	44	37	40	0.76
	Community resources available to help with long-term effects of cancer and it	87	49	45	53	42	46	0.37
	Your family members are at increased risk for cancer	95	54	45	53	50	54	0.88
	Your family members can get information on their risk for cancer	107	60	55	65	52	57	0.28
6-month follow-up (n=180)				85		95
	Type of cancer you have/had	144	80	72	85	72	76	0.19
	Stage of cancer you have/had	142	79	69	81	73	77	0.58
	Treatments you received/are receiving for cancer	152	84	72	85	80	84	0.99
	Things you can do to help prevent your cancer from recurring	87	48	42	49	45	47	0.88
	Long-term physical effects you may experience from cancer and its treatment	88	49	45	53	43	45	0.37
	Strategies for preventing long-term physical effects of cancer treatment	78	43	41	48	37	39	0.23
	Strategies for treating long-term physical effects of cancer treatment	80	44	44	52	36	38	0.07
	Long-term emotional effects you may experience from cancer and its treatment	82	46	42	49	40	42	0.37
	Preventing long-term emotional effects of cancer	88	49	46	54	42	44	0.23
	Strategies for treating long-term emotional effects of cancer treatment	88	49	46	54	42	44	0.23
	Community resources available to help with long-term effects of cancer and it	94	52	52	61	42	44	0.03
	Your family members are at increased risk for cancer	98	55	43	51	55	58	0.45
	Your family members can get information on their risk for cancer	113	63	56	67	57	60	0.44

^*Indicates was significant at Post-Hoc analyses

At 1-month follow up, patients who received the POST continued to report higher ratings of knowledge about community resources available (p=0.004) as well as knowledge of long-term emotional effects from cancer and its treatment (p=0.03), as compared to treatment as usual. There were no significant differences between the groups at 3-month follow-up. At 6-month follow up, the only significant difference between the two groups was patients who received the POST continued reporting greater knowledge related to community resources available (p=0.03).

Interest in mental health or social support services:

After the intervention, patients were able to request mental health or social support services. Patients who received the POST intervention were more than twice as likely to express interest than the treatment as usual (42% vs. 21%, respectively; p-value = 0.002).

Post Hoc Analyses

As a response to the contamination that occurred with the methodology, we conducted Post Hoc Analyses as a way to examine differences between women who received care plans as part of the POST intervention with women who actually received a care plan as part of the treatment as usual condition. Thus, we replicated all of the analyses examining CSI and QOL comparing these two groups of women. Like the primary analyses, these two groups did not differ in any of the QOL analyses. For CSI outcomes, at enrollment, there were no differences, similar to the primary analyses that compared the full sample of treatment as usual to the full sample of POST participants. However, at baseline, there were some slight changes in the results. Specifically, in these Post Hoc analyses, three of items became non-significant (see Table 5).

At one-month follow up, one item moved from non-significant to significant. This item asked if the patients felt confidence in preventing long-term emotional effects of cancer. For the primary analyses this item was not significant (p=.10); however, when comparing only the women who received care plans in the two groups, this item reach significance at a p=.03 level and suggested that women who received the POST survivorship plan felt significantly more confident in preventing long term emotional effects of cancer as compared to those who received the cancer hospital’s treatment as usual care plan.

Discussion

The purpose of this study was to further the existing literature that has examined the impact of survivorship planning on patient outcomes, using a randomized controlled trial design. The POST intervention did not improve QOL at any of the follow up assessments, nor did the treatment of usual. Although this was unfortunate, it was not surprising as QOL is a global construct that is influenced by many aspects of a person’s life. A number of other researchers have reported null findings in their attempts to study the influence of survivorship care planning on QOL.^3,6,11,20,21 The original recommendations from the Institute of Medicine (2006), as well as other cancer care governing bodies^2,22 have suggested that care planning should meaningfully impacting quality of survivors’ lives. Given the number of studies that have not found this to be the case, and one that showed a deleterious impact on QOL,¹⁰ the suggestion that care planning should be done to affect QOL should be discussed further.

We did find that the POST intervention improved confidence. At enrollment, which was pre-intervention, the women who received the POST versus treatment as usual did not differ in their overall confidence ratings or the subscales. Once the interventions were completed, and right before patients left the last health care interaction (i.e., baseline), confidence ratings were reassessed. At baseline, women who received the POST intervention had significantly greater overall confidence, confidence in knowledge about prevention and treatment, and confidence in knowledge of past cancer diagnostics and treatment, compared to the women who received treatment as usual. Thus, it appears that the POST had some impact on the patients’ feelings of confidence as they completed their active treatment for cancer and entered into the world of survivorship. However, this boost in confidence was fleeting as by one month follow up the women who received the POST were only greater in confidence regarding knowledge about prevention and treatment as compared to treatment as usual, and by 3 and 6 months both groups looked similar in their ratings of confidence (Figures 1, 2, and 3).

Figure 2.

Mean confidence in knowledge about prevention and treatment

The literature may benefit from further examination into the impact of high confidence on future behaviors in cancer survivors. Health behavior theories, including Bandura’s Self Efficacy Model²³ and the Health Belief Model²⁴ have pointed to confidence as an important of health behavior change. It would be interesting to examine if patients with high confidence versus low confidence actually changed their health behavior choices (e.g., diet, exercise, smoking, alcohol use) or health care use behaviors (e.g., adherence to future scans and appointments, overall utilization) in survivorship.

A more granular look at the CSI items (Table 3), shows the specific areas of confidence the patients in the POST rated higher than those patients in treatment as usual. At baseline, 1-month, and 6-month follow up, there was a continual difference between the two groups in that POST patients felt more knowledgeable about community resources available. Because of this finding, we investigated differences in the two groups regarding interest in mental health and social services at the end of the intervention. Indeed, a greater confidence in community resources may be related to the increased interest in mental health and social support resources found in the POST group as women who received the POST were almost twice as likely to request a referral for mental health and social support services than women who received treatment as usual. Previous researchers have found survivorship care planning may increase interest and knowledge of support services. Rosenberg and colleagues (2015)²⁵ found that 98% of their sample who received care plans reported a “better appreciation” for available community/support services, and 91% of participants believed the care plan was helpful in its ability to identify support services. Jeppesen et al. (2018)²⁶ examined the impact of survivorship care plans on health care use among endometrial cancer survivors and also found that women who received care plans were given more referrals for supportive services that resulted in more participation in additional health care. Finally, Beaupin et al (2018)²⁷ examined care planning in young cancer survivors (ages 18–39) and concluded that care plans urged the young survivors to seek more resources than those without plans.

This study had a number of limitations. We only enrolled women with breast cancer and did not venture into other types of disease, and most of our participants were white/Caucasian/non-Latino, middle to higher socio-economic status, and were primarily receiving radiation for their cancer. Further, as explained in the methods section, the cancer center shifted its approach regarding survivorship planning from ‘care planning when possible’ to ‘care planning for all patients.’ This contaminated the design of our study and posed a few problems. However, our team ensured that we followed the treatment as usual group closely and kept records regarding who received survivorship care plans and the content of the care plans. We determined that 10 women who received the treatment as usual also received the hospital’s care plans. Because of this, we conducted the Post-hoc analyses, which continued to demonstrate that at baseline women who received the POST care plan had higher ratings of confidence in 8 areas of cancer care as compared to those women who received the other care plans. Finally, we also conducted thorough chart reviews of the care plans for both the treatment as usual and the POST groups, and those data will be disseminated in future publications.

Conclusions

In terms of QOL, the present study does not support our theory that the POST would significantly impact QOL in women ending treatment for breast cancer. Given the limitations described above this finding should be interpreted cautiously. Ideally, to answer the question as to whether or not cancer survivorship planning impacts patient outcomes, we would have needed to test the POST against women who did not receive survivorship care plans, as was initially intended. Ethically, this was not feasible as the clinical field was moving towards better care planning to meet accreditation standards. Although we were concerned about the contamination to our study, we were happy to see institutional changes made that would ensure better care planning for patients. It is also possible that a larger sample size would have resulted in different findings as we would have had more power to deal with the statistical analysis adjustments we had to make related to the aforementioned contamination.

Programs, such as the POST, may improve confidence at the end of treatment for cancer as many areas of confidence were higher for women who received the POST intervention. Unfortunately, such confidence was not maintained, except for knowledge of community resources available, and it is unclear as to whether greater confidence yielded meaningful change in patients’ lives as they walk down the path of survivorship. Future research is needed, but it may behoove providers to assess patient confidence at the end of treatment as it could cue providers to ask questions of areas patients may feel less confident, so they can be addressed.

It is notable that the POST intervention did increase interest in referrals for mental health and social support services and may have benefitted patients by improving their knowledge of community resources throughout the first 6 months of survivorship. Oncology providers are faced with an important task for providing quality survivorship care plans to all patients ending treatment for cancer, in addition to all of their other clinical responsibilities. There is often not enough time to meet all the psychological and social needs of survivors. Although our findings are not conclusive, a computerized program, like the POST, which may increase patient interest in mental health resources and treatment, may not only benefit patients but also oncology care providers.