Efficacy of the “PalliActive Caregivers” intervention for caregivers of patients with cancer in palliative care

Abstract

Background

Family caregivers of patients in palliative care in low- and middle-income countries need intervention. This study aimed to determine the efficacy of the nursing program “PalliActive Caregivers,” on increasing role adoption, the perception of social support, and the quality of life of family caregivers of cancer patients in palliative care in a healthcare institution in Medellín, Colombia.

Method

A controlled randomized trial was conducted from June through December 2022. The study included adult caregivers for patients with cancer in palliative care. A 1:1 randomization method was used. The experimental arm received two individual sessions with an educational booklet and a mobile application for support (approximately 15 and 75 min). The control arm received two hours of group education about symptom management. Sociodemographic variables, as well as quality of life, role adoption, and perception of social support, were measured before the intervention and at two- and four-weeks post-intervention.

Results

One hundred fifteen family caregivers were randomized (experimental, n = 58; control, n = 57). At two weeks post-intervention, caregivers in the experimental group reported significantly greater role adoption (98.55 vs. 87.28, p < 0.01), better perceived social support (83.83 vs. 72.96, p < 0.01), and better quality of life in three of its dimensions (caregiver status, caregiver perspective, relationships) than did the controls. The efficacy of the intervention was evident at the first post-measurement; however, significantly higher scores were observed only at four weeks post-intervention on role adoption (103.79 vs. 87.36; p < 0.01), and for three dimensions of quality of life.

Conclusions

Compared with conventional care, the PalliActive Caregiver intervention significantly improved caregiver role adoption and the perception of social support among caregivers of cancer patients in palliative care. It is recommended that future studies evaluate the effect of the intervention on patient outcomes.

Trial registration

This trial is registered in ClinicalTrials.gov “Uncertainty in Illness in Palliative Care: an Intervention for Family Caregivers” with registry number NCT12345678, registered on 2018-05-14.

Introduction

Palliative care (PC) needs have increased worldwide [1]. Patients with cancer in PC require not only the accompaniment of healthcare professionals but also the support of their family caregivers, who are often responsible for the patient’s care during the disease process [2]. Most research recognizes the role of caregivers in making decisions about the disease and treatment, seeking help, assisting with basic activities of daily living, managing symptoms and medication, providing emotional support for the patient and the rest of the family, and anticipating future events [3]. Given this responsibility of the caregiver to care for the patient, those who assume the role of caregiver without prior preparation and education may experience anxiety [4], depression [5, 6], burden [4], social isolation, uncertainty, and physical problems, such as malnutrition, back pain, and gastrointestinal problems [4, 7].

Consequently, it is essential to educate and support informal, unpaid family caregivers, enabling them to provide adequate care for the patient while also safeguarding their own well-being throughout this process [2]. Although there are several nursing interventions for caregiver support have been reported in two systematic reviews for caregiver support [2], the interventions analyzed were developed in high-income, English-speaking countries where the development of PC and its integration into the health care system is advanced [8]. In contrast, there have been no interventions reported in low-and middle-income countries where the development of PC and its integration into health-care systems are still limited [8, 9]. Consequently, attention is often focused on the physical issues of the cancer patient in PC, such as symptom management, and the integration of caregivers and care by health services has been neglected [10].

Providing effective educational support to ensure patient and caregiver well-being is one of the objectives included in our previous study [11], which evaluated the feasibility of the “PalliActive Caregivers” intervention for caregivers of cancer patients in PC. This study described a decrease in the level of uncertainty about the illness of caregivers, as well as an increased perception of caregiving skills and the strengthening of their relationships with family members [12]. Content on patient care and caregiver self-care, which was included in our previous study, included information on the management of the main symptoms in PC, caring for the patient’s basic activities of daily living, and activities for caregiver self-care. However, our first work was a pilot clinical trial, and we do not know if it can effectively improve the adoption of the role of caregivers and the social support they receive, since these variables were not included in our previous research [11, 12]. In addition, the recommendations of our previous study suggested that the effect of this intervention should be evaluated longitudinally to determine the degree to which the results are maintained over time.

The adoption of the caregiver role in PC refers to the process by which a family member assumes the responsibility of providing physical, emotional, and instrumental care to a loved one facing a serious life-threatening illness [13]. This role adoption also includes the coping and self-care processes that the caregiver must have to cope with such work [14]. Studies report that it is crucial to address caregivers in this context due to the physical, emotional, and social burdens that this role entails [2]. Strengthening caregiver role adoption through educational interventions has not only been shown to help improve the quality of care given to the patient but also to promote well-being and caregiver resilience and coping, reducing the risk of burnout [15, 16].

Accordingly, and based on the results of our previous work, we focused this controlled trial on evaluating the effect of the designed intervention on improving caregivers’ role adoption, their perception of social support, and the impact on quality of life (QoL). PalliActive Caregivers was designed to educate caregivers of cancer patients in PC in caregiving and symptom management skills, and to support seeking and fostering caregiver self-care [11]. Consequently, the aim of this study was to determine the efficacy of the nursing education intervention, PalliActive Caregivers, in improving role adoption, the perception of social support, and the quality of life of family caregivers of cancer patients in PC in a health institution in Medellín, Colombia. and to evaluate the effects over time.

Method

Study design

An experimental study with experimental and control groups and three measurements over three months were performed. The CONSORT guidelines for the reporting of controlled trials [17] were considered in the reporting of this study. This project was ethically endorsed by Ethics Committee of Clínica Vida, the institution where it was conducted (CEI-0096-02-2022). Additionally, all procedures complied with the World Health Organization’s Declaration of Helsinki. This study was registered with Clinical Trial Registry (ClinicalTrials.gov -Protocol Record NCT03518970, Registration date: 2018-05-14).

Sample, setting and recruitment

The sample consisted of informal family caregivers of cancer patients who were receiving PC at least 18 years of age. We excluded all caregivers who were participating in other educational studies, who had previously cared for a person in PC, who were hired as caregivers, or who did not understand Spanish. We also excluded caregivers of patients who were in their last days of life (according to the patient’s medical history).

We recruited participants from a hospital specializing in cancer patients in the city of Medellín, Colombia over a seven-month period starting in June 2022.

Randomization and blinding

Participants who were invited and agreed to participate in the study were randomized to either the experimental or control group by one of the study investigators. This process was conducted after the participant signed the consent form and baseline measurements were administered (Time 1). Subsequently, the researcher entered the individual’s baseline data into the Randomizer for Clinical Trial Lite mobile phone application to perform random assignment to each of the groups. The allocation ratio for each of the groups was 1:1. Participants did not know their allocation, and research assistants responsible for data collection were blinded to group assignment to minimize bias.

Intervention

A nursing intervention, PalliActive Caregivers, designed and pilot tested in another study [11] was used in this study. This educational-type nursing intervention is a two-session face-to-face intervention with a total duration of 90 min. The intervention was delivered by a PC nurse with ten years of clinical experience who followed an intervention protocol designed by the investigators. Details of the content, materials and steps of the intervention are described in Table 1.

Table 1.

Intervention characteristics of PalliActive caregivers

Basis
The PalliActive Caregivers intervention addresses the needs of caregivers in caring for cancer patients in PC.
Procedures:
First meeting: Recognition of the PC nurse and delivery of educational booklet (15 minutes).
Objectives:
- To identify topics needed to increase knowledge in the care of the cancer patient in PC.
Components:
1. Delivery of the educational booklet: the participant receives a visit from the nurse who introduces herself with the participant to be recognized by the person as an authority with credibility and establish a bond of trust. The nurse introduces the participant to the educational booklet that will be given to the caregiver at that moment. The caregiver is asked to read it in its entirety. Afterwards, the nurse makes a new appointment according to the person's availability.
Second meeting: individualized educational encounter (two to three days later. 60 to 90 minutes).
Objectives:
- To acquire knowledge in front of the care of the cancer patient in PC in symptom management and assistance in activities of daily living.
- To plan the care of the cancer patient in PC and self-care strategies in the role of caregiver.
- Recognize the social support available to the caregiver of the cancer patient in PC
Components:
1. Atmosphere of trust: an atmosphere of trust is established in which the nurse asks about how the caregiver feels, how the patient is doing, and what the health professionals have told him/her regarding the patient's illness and its prognosis. The nurse adopts an attitude of listening and full attention (10 minutes).
2. Socialization of the general content of the booklet: the nurse explains the main care suggestions described in the booklet, and emphasizes the definition of PC (20 minutes).
3. Discussion of symptom management and other care activities: the family member is asked what symptoms the patient has and according to the answer, she gives an explanation and strategies for the management of the symptoms found. Here the mobile application is also used to explain other aspects of the patient's care (25 to 30 minutes).
4. Resolution of doubts and expression of emotions: a space is opened in which the person is allowed to express his/her doubts regarding the content of the educational material, how to perform patient care or how to seek social support. A space is also allowed for the expression of their feelings in relation to their role (10 to 15 minutes).
5. Closing ideas: a summary of what was discussed, and a closing of the session is made. The person is invited to ask for the last time if there are any doubts and is invited to use the materials.
Materials
The intervention is performed face-to-face. The first moment lasts 15 minutes. The second moment takes place two to three days after the first moment and lasts approximately one hour.
Content
First meeting: recognition of the PC nurse and handing out of educational booklet (10 min).
1. Illustrated educational booklet:"PalliActive Caregivers: a practical guide for family caregivers". This 30-page booklet addresses the following topics: definition of PC and caregiver. Care for the patient's physical well-being (hygiene, mobilization, feeding and hydration). Symptom management (pain, constipation, diarrhea, dyspnea, nausea, vomiting, fatigue and wounds). Use of social support, psychological and spiritual well-being and self-care of the caregiver.
Second meeting: individualized educational encounter
2. Illustrated educational booklet: described above.
3.Smartphone application:"PaliActivos"available for free in Google Play Store. In this application, five interactive contents were designed on aspects such as patient care like gastrostomy management, bladder catheter, subcutaneous line, bed bathing and pain medication management. Each of these topics in turn is presented in sections: definition, uses, precautions, care, and warning signs.

Control

The usual care at this hospital consisted of face-to-face assistance and education by a general nurse with two years of PC experience. Education included information on symptom management, use of analgesics, and general patient care prior to discharge. Caregiver training sessions were conducted in the patient’s room for approximately 30 min to 1 h. In this type of care, no specific support resources or support strategies were directed toward the caregiver.

Data collection

Measurements in this study were taken at Time 1 (baseline): post-signing of informed consent; Time 2: two weeks post-intervention (three weeks post-recruitment); and Time 3: four weeks post-intervention (seven weeks post-recruitment) to assess the sustained effect over time of the intervention. Time 1 data were collected in the hospital waiting rooms after the participants signed the informed consent form; Time 2 data were collected both in the hospital and by telephone; and Time 3 data were collected via telephone calls made by the research assistants.

The variables selected were congruent with the type of intervention; in addition, recommendations given in the published pilot studies of this intervention were considered [12]. The first outcome variable was the adoption of the caregiver role measured by the ROLE instrument [18], which is composed of 22 items and three dimensions: (1) role tasks, (2) role organization, and (3) responses to the role. The items were scored on a five-item Likert scale. The total scale scores ranged from 22 to 110 points; the higher the score, the better the role adoption.

Another outcome variable was the caregiver’s perception of social support measured with the MOS Social Support Survey, which focuses on the perception of helpfulness [19]. The instrument measures functional support through 19 items distributed throughout the following four dimensions: emotional support, instrumental support, positive social interaction, and affective support. These items were scored on a five-point Likert scale, with scores ranging from 19 to 95 points; the higher the score, the greater the perceived social support.

A secondary variable focusing on the overall impact of the intervention on caregiver well-being was QoL measured with the Quality of Life in Life-Threatening Situations Family Version (QOLLTI-F) questionnaire [20]. This questionnaire contains 16 items and 7 dimensions: environment, patient status, caregiver status, caregiving perspective, caregiving quality, relationships, and financial concerns. The items were scored on a scale ranging from 0 to 10. The range of total scores was 0 to 160, with higher scores indicating better QoL.

All the instruments used have reported adequate psychometric properties with caregivers of PC patients in the Spanish language and in the Colombian context, so they were considered appropriate for use in this research [18, 21, 22].

Sample size

The sample size was calculated based on a repeated-measures ANOVA test, considering an effect size of 0.15 and a Type I error probability of 0.05 and a power of 0.95, with two groups and three measurements, which yielded a total of 116 participants. However, in our pilot trial, 65% of participants completed the study and in other similar studies the attrition rate was as high as 40% [23]. Therefore, we anticipated that a follow-up rate of approximately 60% would be realistic in our setting. Therefore, we anticipated that a sample size of 194 would be adequate (i.e., 60% of 194 = 116).

Analysis

Analysis

The information was analyzed using the SPSS 26.0 program. Sociodemographic variables were evaluated with measures of frequency and central tendency. To determine the differences between groups across measurements, the normality of the data was first analyzed with the Kolmogorov-Smirnoff test.

To compare the variables across the three time periods (Time 1, Time 2, and Time 3), data analysis began with a repeated-measures ANOVA test. This analysis allowed us to evaluate the significant differences in the variables between the three time periods. P-values < 0.05 considered to indicate statistical significance. In addition, effect sizes were calculated for all comparisons (Table 3).

Table 3.

Comparisons between caregivers in the experimental group and the control group

	Time 1				Time 2				Time 3
	Mean (SD)				Mean (SD)				Mean (SD)
Caregiver variable	Experimentalgroup	Controlgroup	Effect size	F [p]	Experimentalgroup	Controlgroup	Effect size	F [p]	Experimentalgroup	Controlgroup	Effect size	F [p]
Role adoption	88.02 (10.69)	90.81 (8.90)	−0.02	2.30 [.13]	98.55 (3.31)	87.28 (10.97)	0.11	55.95 [.001]	103.79 (2.19)	87.36 (10.36)	0.19	79.68 [.001]
Social support	76.0 (16.47)	77.95 (16.05)	−0.00	0.41 [.52]	83.83 (7.59)	72.96 (16.88)	0.04	19.90 [.001]	81.97 (9.32)	77.69 (15.10)	0.02	1.99 [.16]
Quality of Life	99.47 (13.59)	102.47 (13.36)	0.67	2.63 [.17]	122.15 (19.28)	114.86 (20.17)	0.24	3.93 [.053]	122.58 (14.38)	117.26 (20.44)	0.30	1.55 [.21]
Dim 1 Environment	15.17 (4.27)	14.77 (5.10)	0.00	0.20 [.64]	15.24 (4.36)	15.35 (4.45)	−0.00	0.01 [.89]	14.91 (4.03)	15.33(4.40)	−0.01	0.17 [.67]
Dim 2 Patient status	8.03 (3.14)	7.53(3.41)	−0.29	0.69 [.40]	7.59 (1.10)	8.26 (2.42)	−0.69	3.73 [.05]	8.16 (2.08)	7.81 (2.45)	−0.47	0.39 [.53]
Dim 3 Caregiver status	27.16 (7.83)	26.35 (7.93)	0.20	0.29 [.58]	36.37 (6.82)	27.56 (6.49)	0.40	50.29 [.001]	34.67 (6.54)	28.53 (6.94)	0.36	14.56 [.001]
Dim 4 Caregiver perspective	16.22 (1.94)	16.11 (2.05)	−0.92	0.14 [.74]	25.77 (3.82)	19.45 (1.31)	−0.54	139.82 [.001]	24.79 (3.30)	19.64 (1.01)	−0.62	85.32 [.001]
Dim 5 Caregiving quality	16.93 (4.56)	17.30 (3.31)	0.02	0.24 [.62]	16.12 (4.44)	15.88 (4.88)	−0.23	0.07 [.78]	16.76 (4.02)	17.18 (4.21)	−0.24	0.18 [.66]
Dim 6 Relationships	9.40 (1.43)	9.39 (1.14)	−0.93	0.002 [.96]	18.07 (2.05)	11.26 (1.80)	0.16	355.90 [.001]	17.06 (2.63)	13.50 (2.52)	0.01	33.92 [.001]
Dim 7 Financial concerns	6.55 (2.92)	5.96 (3.24)	−0.12	1.03 [.31]	6.41 (2.58)	6.16 (2.91)	−0.62	0.24 [.61]	6.90 (1.93)	6.32 (2.32)	−0.76	1.20 [.27]

SD Standard deviation, Dim Dimension

Results

During a nine-month recruitment period, 1706 caregivers of hospitalized PC patients were evaluated for entry into the study. Of these, 1464 did not meet all the inclusion criteria. To reach the initial calculated sample of 116 participants, it was necessary to include 242 caregivers who completed the baseline measurements.

Of these 242 participants, 115 (48%) completed the measurements at Time 2, and 70 completed the measurements at Time 3 (29%). The final sample for analysis at Time 2 consisted of 58 participants in the experimental group and 57 in the control group. At Time 3 the sample consisted of 33 participants in the experimental group and 37 in the control group. Analysis of participants at Time 3 was performed only with those who completed measurements at both Time 2 and 3. When comparing the intervention and control groups, no significant differences were found in the number of follow-ups, or in the number of participants lost to follow-up. Among the 172 participants who did not complete the study, the reasons included loss of contact at follow-up (38%), death of the patient (19.8%), request to withdraw from the study (7%), patient in the last days of life (5.3%), and refusal to receive the intervention (0.8%) (Fig. 1). No harms were reported during the development of the interventions.

Fig. 1.

CONSORT flow diagram

Ninety-one participants were female (79.1%) and 24 male (20.9%). The percentage of female participants was similar across both study groups (experimental 41.7% vs. control 37.4%). The mean age for the 115 participants was 43.79 years (SD = 13.81, min 19, max 74). Most of the participants had an educational level of high school (34.8%), followed by technical studies (30.4%). In relation to marital status, 58.3% had a partner (married or common-law marriage). Most of the participants were cared for by their parents (38.3%). This was followed by their partner (24.3%), friends (22.6%) and other relatives (14.8%). On average, the participants had been caregivers for approximately six months (min 1 month, max 84 months). With respect to the living arrangement, all caregivers in both groups resided in the same household as the patient (Table 2).

Table 2.

Sociodemographic characteristics of the caregivers

Characteristics	Experimental Group (N = 58)	Control Group (N = 57)	P value
	Number (%)	Number (%)
Sex
Female	48 (41.7)	43 (37.4)	0.33
Male	10 (8.7)	14 (12.2)
Age, mean (SD)	41.74 (12.93)	45.48 (14.7)	0.11a
Educational level
Primary school	6 (5.2)	9 (7.8)	0.11
High school	25 (21.7)	15 (13.0)
Collage	17 (14.8)	18 (15.7)
University studies	10 (8.7)	15 (13.0)
Marital status
Single	26 (22.6)	22 (19.1)	0.49
Married/Common-law marriage	32 (27.8)	35 (30.4)
Occupation
Homemaker	22 (19.1)	24 (20.9)	0.15
Employee	19 (16.5)	14 (12.2)
Self-employed	15 (13.0)	14 (12.2)
Student	2 (1.7)	5 (4.3)
Time as a caregiver in months, median, (rank)	5.50 (47)	6 (84)	0.75b
Socio-economic status
Low income	25 (21.73)	25 (21.73)	0.92
Middle income	31 (26.95)	30 (26.08)
High income	2 (1.72)	4 (3.47)
Type of relationship
Parents	23 (20.0)	21 (18.3)	0.64
Spouse	13 (11.3)	15 (13.0)
Friends	14 (12.2)	11 (10.4)
Other relatives	8 (7.0)	9 (7.8)
Patient’s gender
Female	34 (29.6)	37 (32.2)	0.48
Male	24 (20.9)	20 (17.4)
Patient’s age, mean (SD)	56.28 (14.95)	59.72 (14.45)	0.21a
Patient functional status, mean (SD)	60.17 (16.70)	62.28 (17.52)	0.51b

SD Standard deviation

^a t test

^b Mann-Whitney U test

The average age of the patients who were cared for by the participants was 58 years, they were mainly female (61.7%), and had a functional status with a mean score of 58 points on the Karnofsky scale (min 20, max 90) (Table 2). There were no significant differences between participating caregivers or their patients in the intervention and control groups in sociodemographic characteristics, or in the study variables at baseline, which demonstrates the effectiveness of the randomization process.

Intervention effects

Table 3 describes the means and standard deviations of measurements for experimental and control group participants at measurements at Times 1, 2, and 3. Several effects of the intervention were found for the participating caregivers. On role adoption, caregivers in the intervention group reported better role adoption than did the controls at Time 2 (mean score, 98.55 vs. 87.28; p < 0.01) and at Time 3 (mean score, 103.79 vs. 87.36; p < 0.01).

In relation to social support, differences were found between participants in both groups. Caregivers in the experimental group had significantly more perceived social support than did those in the control group at Time 2 (mean score, 83.83 vs. 72.96; p < 0.01). However, this effect was not maintained at Time 3 (mean score, 81.97 vs. 77.69; p = 0.16) (Table 3).

Regarding QoL, the repeated-measures ANOVA results indicated no significant changes across the different time points between caregivers in the experimental and control groups. Therefore, the authors performed analyses within the QoL dimensions to compare whether there were changes in these subdimensions (Table 3). The analyses showed that participants in the intervention group reported better QoL levels on the caregiver status dimension than did the controls at Time 2 (mean score, 36.37 vs. 27.56; p < 0.01) and Time 3 (34. 67 vs. 28.53; p < 0.01). Caregiver perspective at Time 2 (mean score, 25.77 vs. 19.45; p < 0.01) and Time 3 (mean score, 24.79 vs. 19.64; p < 0.01). Relationships at Time 2 (mean score, 18.07 vs. 11.26; p < 0.01) and Time 3 (mean score, 17.06 vs. 13.50; p < 0.01).

Discussion

The findings demonstrate that caregivers receiving the PalliActive Caregivers Intervention reported markedly higher levels of role adoption than their counterparts in the control group. Several studies that have documented the urgent need for caregivers to acquire instrumental skills for patient care, especially in PC where there is greater complexity in the patient’s treatment [2]. In our study, a superior adoption of the role of caregiver first implies greater knowledge to execute the tasks of the role, i.e., basic, and instrumental care of daily life, as well as those directly related to the disease. Second, improved organization of the role, i.e., identification of and timely access to their support networks, and third, a better response to the role, which is related to the negative impact of caregiving.

The results of this study suggest that role adoption can be addressed and that there are specific strategies to increase the caregiver’s sense of competence in the role. Key strategies of the PalliActive Caregivers intervention are outlined in the booklet section on symptom management, co-developed with participants, and include opportunities for caregivers to clarify care-related questions with the nurse. According to a scoping review on interventions for caregivers in PC, a pattern of success, in some cases, was found to be related to the short duration of the intervention both in the number of sessions and in the time allotted for each one [24]. These reported characteristics coincide with our intervention, which was developed in two sessions and in periods no longer than 60 min [24]. In Latin America, the duration of the PalliActive Caregivers intervention can be an advantage, since it can be replicated by health professionals who have little time to intervene with caregivers.

Another important finding of this study was that caregivers who participated in the experimental group reported significantly greater perceptions of social support than did those in the control group; however, this change was not sustained over time. Higher levels of social support were evident only at the two-week post-intervention follow-up, but not at the four-week follow-up. According to these results, it is possible that the lack of a sustained effect over time is related to the intervention dose and the timing of the follow-up. Caregivers who received the PalliActive Caregivers intervention were told how they could seek social support, both from their primary support network and from other sources of support, such as patient organizations and health care professionals in the hospital (especially social workers).

The first post-measurement in both groups was two weeks after receiving the intervention in the hospital. At this time, some of the participants’ patients were still hospitalized or had recently been discharged, which may have meant that their perception of support from professionals and friends was still high. However, in the second post-measurement, four weeks after the intervention, all caregivers in the study were with the patients at home, and the possible perceptions of support and closeness that they felt during or immediately after the hospital stay had faded. Likewise, some authors have shown that the perception of social support and mobilization of resources by family and friends occurs to a greater extent during critical moments, such as the diagnosis of an illness, hospitalization, or bereavement, but this type of support lessens over time as the critical event passes [25].

Another explanation may be, as mentioned above, due to the dose of the intervention. For example, other research has shown that the strongest effects of the intervention are found in the early post-medications and that follow-up doses are possibly required to maintain the long-term effect [24]. The results of this study suggest that further research is required regarding the dose of the intervention and its relationship with perceived social support, especially among caregivers of cancer patients in PC for whom, as the disease progresses, more support is required for both the care of the patient and for the caregiver’s own accompaniment [26].

The present study revealed no significant differences in the total QoL levels of participants in the intervention group compared with the controls. This main finding led the researchers to analyze the effect of the intervention on each of the QoL dimensions. Although in the case of such a controlled trial, it is important to analyze a single score that represents the effect of overall QoL, some authors point out that it is important to assess caregiver status in multiple domains [27]. For example, significant improvement in some domains and deterioration in others may be observed. In this study, we found that the group that received the PalliActive Caregivers intervention reported better QoL in the dimensions of caregiver status, caregiving perspective, and relationships that refer to conditions directly related to the caregiver, such as physical, emotional, or spiritual well-being, as well as the caregiver’s relationships with the patient and the support network. In particular, the experimental group received education on how to improve psychological, spiritual, social, and physical well-being through the designed educational booklet. In contrast, in this research, no significant differences were found in the dimensions of patient status, environment, quality of care, or financial concerns between the experimental and control groups. These dimensions are closely related to issues external to the caregiver, which were not addressed by the PalliActive Caregivers intervention, such as financial concerns that may depend on the financial support received by the caregiver and the quality of care that is influenced by the quality of care received, or the patient’s condition, which in the case of a person in PC fluctuates.

While other research has shown that QoL is the gold standard of caregiver care in PC [24], our results add to the debate about the feasibility of measuring the effect of interventions on QoL in PC. Some authors argue that the effects of studies on both short- and long-term QoL are limited and recommend the measurement of other more proximal variables in the experience of being a caregiver [28]. Even the degree to which QoL may improve in patients with terminal cancer whose disease causes progressive deterioration has been analyzed [29]. In this regard, the results of this study are novel and open the possibility of studying the impact of interventions on QoL more sensitively through each of its dimensions. This is in line with new trends that seek to assess the impact of interventions with specific outcome measures for the intervention being evaluated, which ensures that the effects of treatment are captured rather than relying only on global results [30].

Several limitations are acknowledged in this study. First, the attrition rate in this study was high, but within the limits expected for studies in PC. Although the characteristics of the participants who completed the study were compared to ensure that both groups were equal, and although the reasons for their withdrawal from the study are known, there could have been a selection bias caused by not knowing the characteristics of those participants who dropped out of the study, which could affect the representativeness of the population and the generalizability of the results. Second, the measurements of this intervention were performed in two different contexts. For the first measurement (Time 1) and in some of the second measurements (Time 2) the participants were with the patient in the hospital, but in the third measurement all participants were at home. This could have affected both their responses to being in a critical context (hospital) and later in a familiar environment (home). Issues such as the perception of support and responsibility for patient care, may change in both settings and this could have influenced participants’ responses. Finally, although one of the exclusion criteria was caring for a patient in the last days of life, in this study the rate of attrition due to patient mortality was considerable. This could indicate that some caregivers who completed the intervention had patients in the last days of life, and consequently, this influenced the effects of the intervention.

Several limitations are acknowledged in this study. First, the attrition rate in this study was high, but within the limits expected for studies in PC. Although the characteristics of the participants who completed the study were compared to ensure that both groups were equal, and although the reasons for their withdrawal from the study are known, there could have been a selection bias caused by not knowing the characteristics of those participants who dropped out of the study, which could affect the representativeness of the population and the generalizability of the results. Second, the measurements of this intervention were performed in two different contexts. For the first measurement (Time 1) and in some of the second measurements (Time 2) the participants were with the patient in the hospital, but in the third measurement all participants were at home. This could have affected both their responses to being in a critical context (hospital) and later in a familiar environment (home). Issues such as the perception of support and responsibility for patient care may change in both settings and this could have influenced participants’ responses. Third, another limitation is that the PalliActive intervention primarily focused on patient management and caregiver support, while other important aspects of caregiving—such as caregiver satisfaction, advance care planning, legacy-building, and meaning-making—were not addressed. This scope may have limited the potential impact on role adoption and quality-of-life outcomes. Finally, although one of the exclusion criteria was caring for a patient in the last days of life, in this study the rate of attrition due to patient mortality was considerable. This could indicate that some caregivers who completed the intervention had patients in the last days of life, and consequently, this influenced the effects of the intervention.

Some clinical implications can be observed from the evidenced effect of the PalliActive Caregivers intervention on caregivers. The role of being a caregiver of a person with cancer in PC can be taught through educational interventions, despite the context in which the disease develops. Strategies, such as education about the disease, symptom management, and basic patient care, are necessary to benefit the adoption of the role of caregiver. Likewise, the accompaniment of caregivers should include strategies to guarantee their own self-care, since frequently the education they receive is only related to patient care. On the other hand, the results of this study support the arguments for evaluating the effects of interventions with outcome variables that are much more sensitive to changes, as is the case for analysis by dimensions or items of a construct or with other types of designs such as mixed designs [31]. Finally, future research should evaluate the dosage of this intervention and its relationship with both short- and long-term outcomes.

Conclusions

In summary, this study provides an evaluation of a nursing education intervention for caregivers of cancer patients in PC (PalliActive Caregivers). Caregivers who received the designed intervention reported better role adoption and greater perceived social support at two weeks post-intervention that did those in the control group. Although the study found no effect of the intervention on overall QoL, a positive impact on the caregiver status, caregiving perspective, and relationships dimensions of caregiver QoL was identified. Given the level of development of PC in Latin American countries, more interventions are needed to include and empower caregivers of cancer patients in PC and thus improve the support they receive from the health system and health professionals.

Authors contributions

MAR was responsible for the conceptualization of the study, securing resources, designing the methodology, conducting formal analysis, administering the project, acquiring funding, and writing both the original draft and subsequent reviews and edits of the manuscript. EAH contributed by collecting and curating data, as well as reviewing and editing the manuscript. SCM was involved in the conceptualization of the study, conducting formal analysis, and writing both the original draft and subsequent reviews and edits of the manuscript. All authors participated in critically reading and revising the manuscript and gave their final approval for the submitted version.

Funding

The present study was funded by the research division of the University of Antioquia in Medellín, Colombia through folio number: 2020_33736.

Data availability

No datasets were generated or analysed during the current study.

Declarations

Ethics approval and consent to participate

The study was approved by the Ethics Committee of Clínica Vida in Medellin Colombia (no. CEI-0096-02-2022). The study was carried out in accordance with World Health Organization’s Declaration of Helsinki - Ethical Principles for Medical Research. This implies that the family caregivers were informed in writing and orally about the study, participation was voluntarily, and they could withdraw from the study at any time without any consequences, and finally that data was handled confidentially. All participants provided written informed consent.

Consent for publication

Not applicable. In this study, the data were aggregated and reported at the group level rather than for individual family caregivers. Each participant was informed that their identity would remain anonymous in the published results.

Competing interests

The authors declare no competing interests.