Living Well With Uncertainty in Advanced, Metastatic or Incurable Cancers: A Pragmatic Feasibility Study of the Adapting to Life With Cancer Cognitive ExisteNtial Therapy (ACCENT)

ABSTRACT

Background

New treatments are contributing to individuals living longer with advanced, metastatic, or incurable (AMI) cancers. The impact of these treatments is unpredictable, resulting in considerable uncertainty for these patients. Currently, there are no interventions that effectively address uncertainty in AMI cancers. To fill this gap, we designed the Adapting to life with Cancer Cognitive ExisteNtial Therapy (ACCENT) intervention.

Aim

To evaluate the feasibility, acceptability, and preliminary efficacy of ACCENT in AMI cancers.

Methods

ACCENT was delivered online for 6 consecutive weekly sessions of 1.5 hours to five groups of six to seven patients. Thirty‐two patients were interested in participating, but 2 did not complete the assessments pre‐ or post‐intervention. A pragmatic feasibility study was conducted using data collected in routine clinical practice. Participants completed the Intolerance of Uncertainty Scale—Short Form, the Generalized Anxiety Disorder scale, and the Impact of Events Scale before and after the intervention. Post‐intervention, participants answered open‐ended questions to assess acceptability, rated their perceptions of improvement and usefulness, and completed the Satisfaction with Therapy and Therapist Scale.

Results

ACCENT appears feasible with participants completing the intervention and all assessments between January 2022 and November 2023. It appears acceptable with an attrition rate of 12.5%, and a high degree of attendance and satisfaction. There was a non‐significant decrease in intolerance of uncertainty, and a significant decrease in anxiety, and cancer‐specific distress post‐intervention.

Conclusion

A randomized controlled pilot study is warranted to further evaluate ACCENT in patients with AMI cancers.

1. Introduction

Forty‐six percent of Canadians will be diagnosed with cancer in their lifetime [1]. The overall age‐standardized incidence rates for cancer have slowly declined over the last 3 decades; however, the number of individuals being diagnosed with and treated for cancer is rising owing to a growing and aging population [2]. Individuals living with cancer are also surviving longer. In 2015–2017, the predicted 5‐year net survival rate for all cancers was 64% compared to 55% in the 1990s and 25% in the 1940s [2]. This is due to improvements in early detection and treatments, especially recent advances in targeted‐, immuno‐, and hormone therapies [3]. Many of these new treatments aim to increase length of life, especially in individuals with advanced, metastatic, or incurable (AMI) cancers [3, 4]. As more individuals are being diagnosed with cancer and living longer, there has been an appropriate shift in attention to the clinical needs of those with AMI cancers [3, 5].

Individuals living with AMI cancers report a range of psychosocial challenges related to the uncertainty inherent in their illness, including anxiety, fear of disease progression, fears about death or dying, and worries about the impact of illness on loved ones and social life [4, 6]. The ability to live well with uncertainty is known to vary considerably across individuals and greater difficulty tolerating uncertainty is associated with poorer psychological adjustment [7, 8, 9]. Systematic reviews including thematic synthesis in AMI cancers suggest that experiences of uncertainty can impact financial, emotional, and social domains, and create unmet practical, informational, psychological, and communication needs in these individuals [6, 10]. Living well with uncertainty thus presents a unique challenge that must be addressed in this population [3, 4, 11].

Interventions that address uncertainty among cancer patients have been researched. A recent review by Guan et al. [12] identified 26 studies that reported on interventions to manage uncertainty in cancer for patients and caregivers. Eighteen of these had positive effects on uncertainty outcomes; however, only five included patients with advanced cancers [13, 14, 15, 16, 17]. Two of these 5 studies involved patients with new diagnoses and disease recurrences, and both reported no significant changes in illness uncertainty following their respective interventions [14, 16]. Of the 3 studies focused exclusively on advanced cancer, one was a purely informational intervention that showed a reduction in decision making uncertainty after patients watched a video decision aid about palliative radiation therapy [13]. The second examined FOCUS, a dyadic intervention for patients with advanced cancer and their family caregivers that addresses themes of family engagement, optimistic attitude, effective coping strategies, dealing with uncertainty, and symptom management [14]. There were no effects of the intervention on primary outcomes including illness uncertainty and quality of life compared to usual care [14]. The third study examined the effect of a Cognitive Behavioral Therapy‐Acceptance and Commitment Therapy (CBT‐ACT) intervention targeting sleep difficulties, worry, depression, and fatigue, with intolerance of uncertainty as a secondary outcome that was not significantly reduced [17]. Thus, to our knowledge, there are no reports of interventions that comprehensively and effectively address the unique challenges associated with the experience of uncertainty for individuals living with AMI cancers. Adapting current interventions that have been successful at addressing uncertainty in early‐stage cancer survivors to the reality of AMI cancers may be a fruitful venue [17].

The Fear Of Recurrence Therapy (FORT) [18, 19, 20], that was developed to address fear of cancer recurrence (FCR) in cancer survivors (stages I‐III) may be particularly suited to adaptation in the AMI population. In a randomized controlled trial of early‐stage cancer survivors, FORT demonstrated its efficacy at reducing FCR and other secondary outcomes (e.g., intolerance of uncertainty, uncertainty in illness, avoidance) [20]. FORT is based on a blended theoretical model of FCR [21] aiming to target key vulnerability factors such as internal and external triggers, exaggerated perceived risk of recurrence, hyper‐focus on ambiguous physical sensations, maladaptive coping, uncertainty around cancer and its treatments or care, intolerance of uncertainty, and beliefs about the benefits of worrying about one's health. The development of FORT [19] was guided by Leventhal's Common Sense Model [22, 23], Mishel's Uncertainty in Illness Theory [24], and the cognitive model of worry [25]. The intervention integrates cognitive and existential based techniques to specifically target FCR during six consecutive weekly sessions of 90–120 min in a group format led by two healthcare professionals trained in psychotherapy.

To meet the clinical need of AMI patients presenting for psychological services within the Psychosocial Oncology Program (PSOP) at a regional cancer center, CH adapted FORT to those with AMI cancers. In doing so, the findings of systematic reviews [6, 10] suggesting that uncertainty is the overarching psychological concern of this patient population were key to determining content. The potential energy limitations of patients was considered in deciding the number of sessions, duration of each session, and the online format. A group format was selected given the benefits derived by patients through group process, and for reasons of cost‐effectiveness [26]. The result is a novel intervention called Adapting to life with Cancer Cognitive ExisteNtial Therapy, or ACCENT, a manual‐based group psychotherapy aimed at addressing key psychological concerns of AMI cancer patients: intolerance of uncertainty, anxiety, and cancer‐specific distress. The purpose of this exploratory study is to improve the quality of this clinical service by assessing the feasibility, acceptability, and preliminary efficacy of ACCENT in AMI cancers using data collected as part of routine clinical practice. If preliminary results indicate that ACCENT is feasible, acceptable, and shows a clinical signal, we will conduct a pilot study to assess the potential clinical utility of this intervention in a more systematic way.

2. Methods

2.1. Design and Outcomes

Using the data collected as part of routine patient care, we framed our evaluation within a pragmatic feasibility study design [27]. Pragmatic feasibility studies focus on the potential benefits of an intervention offered in routine clinical practice. Primary outcomes were feasibility and acceptability of ACCENT in individuals living with AMI cancer.

Secondary outcomes were estimates of preliminary efficacy for intolerance of uncertainty, anxiety, and cancer‐specific distress.

2.2. Participants

As part of routine referral practices, patients living with heterogeneous AMI cancers were referred for potential participation in the ACCENT group by their treating social worker at The Ottawa Hospital Cancer Center Psychosocial Oncology Program in Ottawa, Canada. Participation required the patient to (a) have a diagnosis of AMI cancer; (b) express interest in participating in a group aimed at managing cancer‐related uncertainty; (c) be age 18 or older; (d) speak English; and (e) have access to internet in a private setting. Exclusion criteria were (a) self‐reported major psychological disorder (e.g., cognitive impairment, severe depression, personality issues): that would interfere with group participation. This study was deemed consistent with a quality improvement (QI) effort by the Ottawa Health Science Network Research Ethics Board (OHSN‐REB); thus, REB exemption was provided. For the purpose of outcome monitoring, patients were invited to complete questionnaires pre‐ and post‐intervention, but this was not a requirement of participation in the group.

2.3. Procedures

Patients who met the inclusion requirements were referred from January 2022 to October 2023. Identified participants were contacted by the lead psychologist (CH) over the telephone for screening. Screening consisted of assessing commitment to and suitability of the 6‐week group therapy, openness to the emotional content and existential components, and comfort with the virtual group format. Patients were added to a waiting list and the intervention began as the psychologist's clinical time allowed. Membership was closed once the group was on‐going. Patients provided verbal consent and were invited by CH to complete questionnaires via Microsoft Forms prior to the start of the group and immediately post intervention. The intervention was delivered as part of routine psychological care via The Ottawa Hospital Epic Zoom medical software application by the lead psychologist alone, or with a trainee (i.e., psychology resident or psychiatry resident). Participant attendance was documented, and individual make‐up sessions were offered by the lead psychologist or her trainee to participants who missed a group session.

2.4. Intervention

Adapting to life with Cancer Cognitive ExisteNtial Therapy (ACCENT) is a virtual group psychotherapy delivered by up to two group facilitators that consists of 6 consecutive weekly sessions of 90 min and between session assignments (see Table 1 for a description of each session). The focus of ACCENT is to address uncertainty, anxiety, and distress in AMI cancers. Like FORT, the ACCENT intervention is based on Cognitive Behavioral Therapy (CBT) and Existential Psychotherapy but was adapted to include components of Acceptance and Commitment Therapy (ACT) as ACT has demonstrated efficacy in AMI cancer patients [17]. Table 1 includes a description of the 6 sessions of ACCENT with CBT interventions (e.g., psychoeducation, worry management, cognitive restructuring, coping statements, exposure, relaxation), ACT interventions (e.g., values‐based living, mindfulness), and existential interventions (e.g., exploring and processing fears related to death and dying, prioritizing activities that are perceived as meaningful). Before starting the group, participants are sent an electronic patient workbook describing session activities and assignments.

TABLE 1.

ACCENT session content.

	Content
Session 1	‐Introduction to group process, content, and goals ‐Psychoeducation about uncertainty, consequences of intolerance of uncertainty, continuum of coping including adaptive and unhelpful strategies, self‐reflection ‐Explanation of the cognitive‐behavioral model ‐Worry management through assessment of aspects within versus outside of one's control and corresponding adaptive strategies ‐Progressive muscle relaxation (PMR) ‐Assignment of between session exercises
Session 2	‐Review between session exercises ‐Review the cognitive‐behavioral model ‐Cognitive restructuring ‐Coping statements ‐Guided imagery ‐Assignment of between session exercises
Session 3	‐Review between session exercises ‐Psychoeducation about avoidance and confronting fears ‐Worst‐case scenario exercise ‐Grounding exercise ‐Assignment of between session exercises
Session 4	‐Review between session exercises ‐Process the worst‐case scenario exercise ‐Mindfulness exercise ‐Assignment of between session exercises
Session 5	‐Review between session exercises ‐Psychoeducation about the distinction between values and goals ‐Personal values assessment ‐Planning exercise to live one's values more fully ‐Grounding exercise ‐Assignment of between session exercises
Session 6	‐Review between session exercises ‐Review and discussion of session 1–5 content and process ‐Discussion about continued practice, how to maintain progress, and relapse prevention ‐Process feelings related to the group ending and saying goodbye

2.5. Outcomes

Measures were administered as part of standard of care to evaluate the project's primary and secondary outcomes. All measures were administered in English.

2.5.1. Primary Outcomes

Feasibility was assessed by considering the number of referrals and the refusal rate. Acceptability was evaluated by calculating the attrition rate, adherence rate (attendance), and reported satisfaction (quantitative and qualitative) and perceptions of improvements and usefulness.

2.5.1.1. Satisfaction With Therapy and Therapist Scale‐Revised (STTS‐R) [28, 29]

The STTS‐R was used to assess participants' satisfaction with ACCENT and the therapist(s) post‐intervention. The STTS‐R is comprised of 12 items rated on a 5‐point Likert Scale from 1 (“Strongly disagree”) to 5 (“Strongly agree”). The STTS‐R has strong psychometric properties [29].

2.5.1.2. Open‐Ended Questions About ACCENT

Post‐intervention, participants were asked to write about which program components they liked best and what they would change to make the group better.

2.5.1.3. Post‐Intervention Perceptions of Improvement and Usefulness

Post‐intervention, participants used a 5‐point scale to rate the impact of the group on their ability to manage uncertainty (made things a lot worse, made things somewhat worse, made no difference, made things somewhat better, made things a lot better) and a 5‐point scale to rate their plan to continue using the strategies introduced in the group (definitely not, I don't think so, not sure, I think so, definitely).

2.5.2. Secondary Outcomes

2.5.2.1. Intolerance of Uncertainty Scale—Short Form (IUS‐12) [30]

The IUS‐12 was used to assess intolerance of uncertainty by measuring reactions to uncertainty, ambiguous situations, and the future. It is comprised of two factors, prospective anxiety (seven items) and inhibitory anxiety (five items). All items are rated on a 5‐point Likert scale from 1 (“Not at all characteristic of me”) to 5 (“Entirely characteristic of me”). The IUS‐12 has good psychometric properties [30, 31] and has been used in the cancer population [32].

2.5.2.2. Generalized Anxiety Disorder‐7 (GAD‐7) [33]

The GAD‐7 was used to assess generalized anxiety and frequency of symptoms. It is comprised of seven items rated on a 4‐point Likert scale from 0 (“Not at all”) to 3 (“Nearly every day”). The GAD‐7 has strong psychometric properties [34] including in individuals with cancer [35, 36].

2.5.2.3. Impact of Events Scale (IES) [37]

The IES was used to assess subjective distress associated with cancer. The IES is comprised of 15 items rated on a 5‐point Likert Scale from 0 (“Not at all”) to 5 (“Often”) which reflect intrusive thoughts (seven items) and avoidance symptoms (eight items). The IES has strong psychometric properties [38] and is frequently used in patients with cancer [39].

2.6. Data Analysis

Qualitative data was summarized by co‐author LG rather than undergoing content analysis due to limited responses. Frequent comments were summarized as one while more specific, constructive and actionable feedback was directly reported. Paired samples two‐tailed (p < 0.05) t‐tests were used to compare pre‐ and post‐scores using SPSS. One t‐test per outcome was performed using participants' total scores on each measure. The assumptions for normality and outliers were met: The data were relatively normal as assessed by the Shapiro‐Wilks test for normality and paired t‐tests are robust to the small deviations identified. Outliers were too few to remove and not significant. Due to the exploratory nature of this study, only complete pre‐ and post‐intervention data were used. Analyses explored the clinical signal of the intervention to determine if future, more rigorous, studies of ACCENT are justified.

3. Results

3.1. Participants

Five groups (six to seven participants in each) were completed from January 2022 to November 2023. In total, 32 patients were interested in participating in ACCENT. Eligible participants were included in the groups on a first come first served basis. Of the 28 who took part in the group (4 dropped out), 25 completed both pre‐ and post‐intervention assessments. Due to clerical errors, the IES was not included in the post‐intervention assessment of the first group; therefore, the data for this measure counts five more missing entries than that of the GAD‐7 or IUS‐12. Twenty‐four women and one man provided data. Breast cancer (n = 8) and colorectal cancer (n = 5) were the most common primary cancer types. All participants had AMI cancer. The sociodemographic and medical characteristics of the sample are presented in Table 2.

TABLE 2.

Patient demographic characteristics.

		Frequency (%)
Gender	Woman	28 (93.8%)
	Man	2 (6.3%)
Relationship status	Single	4 (13.3%)
	Married/common law	23 (76.7%)
	Widowed	1 (3.3%)
	Divorced or legally separated	2 (6.7%)
Race	East Asian	1 (3.3%)
	Middle Eastern	2 (6.7%)
	South Asian	1 (3.3%)
	White	25 (83.3%)
	Other	1 (3.3%)
Education	High school	3 (10%)
	College diploma	7 (23.3%)
	University degree	11 (36.7%)
	Master's degree	6 (20%)
	Doctoral degree	2 (6.7%)
	Medical degree	1 (3.3%)
Employment	Full‐time	2 (6.7%)
	Part‐time	3 (10%)
	Retired	9 (30%)
	Unemployed	1 (3.3%)
	Student	1 (3.3%)
	Sick leave (including short‐ or long‐term disability)	9 (30%)
	Disability pension	4 (13.3%)
	Other	1 (3.3%)
First language	English	21 (70%)
	French	4 (13.3%)
	English and French	3 (10%)
	Other	2 (6.7%)
Primary cancer type	Oral	1 (3.3%)
	Uterus	2 (6.7%)
	Lung and bronchus	2 (6.7%)
	Pancreas	1 (3.3%)
	Kidney and renal pelvis	1 (3.3%)
	Breast	8 (26.7%)
	Liver	1 (3.3%)
	Ovary	2 (6.7%)
	Thyroid	1 (3.3%)
	Non‐hodgkin lymphoma	2 (6.7%)
	Colorectal	6 (20%)
	Sarcoma	2 (6.7%)
	Other	2 (6.7%)
Treatment type	Surgery	20 (66.7%)
	Chemotherapy	26 (86.7%)
	Radiation	20 (66.7%)
	Hormone therapy	7 (23.3%)
	Other (i.e., immunotherapy)	5 (16.7%)

3.2. Feasibility and Acceptability

All 32 participants who were referred for the group were contacted, and all agreed to participate in ACCENT. One participant dropped out after completing pre‐intervention questionnaires but before starting the group due to scheduling conflicts. Their data were removed from the analyses. In addition, one participant did not provide data.

Three participants dropped out during the intervention after attending two sessions or less. The reasons for these dropouts were: unexpected rapid health decline (n = 2) and too difficult to hear stories of others (n = 1). Thus, the attrition rate was 4/32 = 12.5%. Of the 28 patients who took part in the intervention, 17 attended all six group sessions (60.7%), 8 attended five group sessions (28.6%), 2 attended four group sessions (7.1%), and 1 attended three group sessions (3.6%). Seven participants attended at least one make‐up session offered on a one‐to‐one basis. The make‐up sessions were not included in the completion statistics listed above. Reasons for missing sessions included health concerns (i.e., fever, treatment side effects, pain) and other medical appointments conflicting with the group time. Figure 1 shows attendance and drop‐out rates.

FIGURE 1.

Drop‐out rates and attrition.

3.2.1. Self‐Reported Satisfaction

Of 30 participants, 25 completed pre‐ and post‐questionnaires. Overall satisfaction with ACCENT and the therapist(s) was high as indicated by subscale scores (satisfaction with therapy mean = 27.9/30, range = 23–30; satisfaction with therapist(s) mean = 28.8/30, range = 24–30) and by the overall mean of 56.6/60 on the STTS‐R (range = 48–60).

Twenty‐five (n = 25) participants reported qualitatively on what they liked best and what they would change about ACCENT. Participants appreciated being able to share their worries with a group of individuals with similar experiences (n = 20). The size of the group was also acceptable (n = 1). The atmosphere of the group was reportedly safe and respectful (n = 8):

I was able to express myself in a safe place with people who are going through the same experience.

Participants appreciated learning new strategies to live with uncertainty (n = 9). Some participants shared their appreciation for the facilitators' empathy and their expertise (n = 8). One participant appreciated the online format:

Strangely enough, the zoom format was conducive to therapy ‐ regardless of energy level, could assist; allows for private moments when discussion is too intense.

Generally, they felt heard, understood, supported, and experienced a sense of community:

Hearing other people's concerns and stories; not feeling alone; being able to share and know that what is shared is understood and felt by others in the group.

The suggested changes included increasing the number of sessions for the intervention (e.g., from 6 to 10; n = 7) and increasing the length of each session (e.g., 1.5–2 h; n = 1). Some participants asked to add a session or two that included caregivers (n = 2), but another wanted the group to be offered only to patients while still including a session on how to communicate with caregivers (n = 1). There were also some participants who wished to separate the groups according to age or cancer type to facilitate more relatable discussions (n = 2).

Maintain criteria of similar cancer condition for group participants (ex. women with breast cancer and metastasis). Maintain focus on cancer patients (keep caregivers therapy separate), but allow for discussion about relations with close caregivers/family members.

Finally, some participants asked to have a mix of in‐person and online sessions (n = 3). Other comments were asking for more explanations on the worst‐case scenario exercise and its utility (n = 2), and having more roleplay exercises (n = 1):

Of all the strategies, the facing your worst fear scenario is the one which I didn't feel helpful. Maybe more explanation would have been good.

When asked if the intervention helped them manage uncertainty, all participants (n = 25) answered that ACCENT “made things a lot better” or “made things somewhat better.” In addition, all (n = 25) reported that they “think” they will or “definitely” will use the strategies learned during the intervention.

3.3. Preliminary Efficacy

Out of 30 participants, a total of 25 complete responses for assessments of anxiety and intolerance of uncertainty and 20 complete responses for cancer‐specific distress were provided. T‐tests revealed a non‐significant decrease in intolerance of uncertainty (n = 25, t (24) = 1.77, p = 0.089), and a statistically significant decrease in anxiety (n = 25, t (24) = 3.61, p = 0.001), and cancer‐specific distress (n = 20, t (19) = 2.23, p = 0.038). Effect sizes were small for intolerance of uncertainty (Cohen's d = 0.36), and moderate for anxiety (Cohen's d = 0.72) and cancer‐specific distress (Cohen's d = 0.50) (Table 3).

TABLE 3.

Paired samples, two‐tailed, t‐test results.

	Baseline mean score	Mean difference	Standard deviation	t	df	p‐value (two‐tailed)	Cohen's d
GAD‐7 (pre‐ & post‐intervention)	8.75/21	3.44	4.77	3.61	24	0.001	0.72
IUS‐12 (pre‐ & post‐intervention)	32.32/60	2.28	6.43	1.77	24	0.089	0.36
IES (pre‐ & post‐intervention)	36.87/75	6.25	12.51	2.23	19	0.038	0.50

4. Discussion

This study reports on the feasibility, acceptability, and preliminary efficacy of ACCENT, a manual‐based psychological intervention designed to help AMI cancer patients live well with uncertainty. To our knowledge, there are no reports of interventions that comprehensively and effectively address the unique challenges associated with the experience of uncertainty for individuals living with AMI cancers. Strengths of ACCENT are that it was adapted from evidence‐based, theoretically driven interventions, based on the identified psychological needs of this population, developed in keeping with the potential energy limitations of those with AMI cancers, and offered in a group format. Specifically, ACCENT adapted FORT, a cognitive existential intervention with demonstrated efficacy in reducing fear of recurrence and uncertainty in early‐stage cancer survivors to focus on the broader construct of uncertainty, which is a key source of distress in patients with AMI cancers [6, 10]. ACCENT also incorporates elements of third‐wave CBT interventions (i.e., ACT) that promote value‐based living. This resulted in a brief, 6‐week manual‐based psychological intervention grounded in theory and explicating the group processes and exercises that clinicians can use to address uncertainty and associated distress in a virtual format (see Table 1).

Findings demonstrated evidence of feasibility, acceptability, and preliminary clinical efficacy. We were able to offer ACCENT to 31 participants in 22 months from a single recruitment site. Anecdotally, the limiting factor to number of groups provided was the psychologist's clinical time rather than patient demand for the service. All individuals who were offered the intervention agreed to participate. ACCENT appears acceptable as few participants (12.5%) dropped out. Of note, one of the dropouts occurred prior to the group beginning due to a scheduling conflict and half of those who dropped out were unable to continue because their health deteriorated rapidly. Rapid health decline may be expected with this population and will be considered for recruitment efforts in future ACCENT efficacy studies. Dropouts tended to occur early in the intervention, after the first or second session, which is typical of patients seeking mental health services [40]. The attendance rate was high with 89% of participants attending five or all of the group sessions. The reasons for missed sessions most commonly included being unwell or attending another medical appointment. Patients were offered individual make‐up sessions and attended them. This suggests that clinicians will need to extend this flexibility when working with the AMI population. Satisfaction ratings were high and qualitative data suggested that the group format and content were valued. Participants expressed feelings of cohesiveness and shared experience. In terms of preliminary efficacy, ACCENT may be successful in increasing the ability to live with the uncertainty inherent in AMI cancers. The non‐significant decrease in intolerance to uncertainty was unexpected. This may have been due to lower base rates and a non‐clinical baseline level of uncertainty at the start of the intervention. Because of the potential mediating role of intolerance of uncertainty between uncertainty in illness and fear of disease progression, it may have been useful to assess for uncertainty in illness in addition to intolerance of uncertainty [41]. Relatedly, uncertainty in illness being an inherent component of AMI cancers, this may have influenced this result [10, 12]. This should be further investigated in future studies and more systematically measured. The intervention may also reduce anxiety and cancer‐specific distress. The preliminary effect sizes of the observed changes were, for the most part, in the medium range [42] and consistent with interventions for uncertainty, fear of cancer recurrence, and anxiety in early‐stage cancer patients [12, 39, 43].

5. Conclusion

This preliminary evaluation of ACCENT was anchored in a pragmatic approach that favors external generalizability over internal validity. There are advantages to this approach, the main one being that ACCENT was evaluated in the context in which it was delivered as a clinical service, which may facilitate future implementation efforts. Another advantage is that ACCENT was offered to groups of patients with mixed primary tumor sites. This will facilitate its future testing and implementation in settings where offering cancer site specific groups is not feasible or desirable. ACCENT was delivered in an online, group format which potentially increases access to the intervention and cost‐effectiveness.

5.1. Limitations

There are also disadvantages to the pragmatic approach: ACCENT was delivered at a single site without the strict methods that are typical of a clinical trial. Lack of a control group and randomization precludes us from determining that the intervention is responsible for the changes observed amongst participants. In addition, inclusion criteria did not involve meeting minimum symptoms scores on self‐report measures which may have contributed to the statistically insignificant finding on the Intolerance of Uncertainty scale. We have no information about compliance of homework or rate of practice of between session exercises. Data were collected by the study psychologist which introduces the likelihood of demand effects. Participation of a single man limits generalizability of the findings, although this is not unique to our study and likely a reflection of gender differences in seeking psychological support [44, 45] Additionally, absence of data on the degree to which ACCENT was delivered as intended and on the ease of using the intervention from the therapists involved could be a limitation. Finally, using a complete‐cases analysis may have introduced bias to the observed changes in anxiety, intolerance of uncertainty and cancer‐specific distress levels. Results from this pragmatic feasibility study should therefore be interpreted with some caution.

5.2. Future Directions

A future pilot study is needed to thoroughly examine feasibility and acceptability outcomes with greater methodological rigor to address the limitations noted above. This would include the feasibility of randomizing people living with AMI cancers to a control group. Additional psychological outcomes that have been reported in this population such as fear of disease progression, uncertainty in illness, and death anxiety could be included as potential outcome variables. Possible modifications include increasing the number of sessions based on participant feedback and having additional sessions with caregivers, for which validated dyadic interventions may be relevant [16].

5.3. Implications for Individuals With Cancer

This pragmatic feasibility study suggests that ACCENT, a 6‐week, manual‐based group psychotherapy to address uncertainty, shows promise for the growing population of individuals living longer with AMI cancers. Future studies are needed to more rigorously test ACCENT.

Conflicts of Interest

The authors declare no conflicts of interest.

Data Availability Statement

The data collected and analyzed in this study are available upon reasonable request.