Tsianakas, V., Robert, G., Richardson, A., Verity, R., Oakley, C., Murrells, T., . . . Ream, E. (2015). Enhancing the experience of carers in the chemotherapy outpatient setting: An exploratory randomised controlled trial to test impact, acceptability and feasibility of a complex intervention co-designed by carers and staff. Supportive Care in Cancer, 23, 3069–3080. 

To test the feasibility and acceptability of a codesigned (caregiver and healthcare provider) Take Care intervention, and to measure caregiver knowledge, information needs, confidence, and emotional well-being related to intervention efficacy

The Take Care intervention included a 19-minute DVD designed to offer education, information, and support to the caregivers of patients starting chemotherapy. It also included a booklet and a one-hour protocol-guided group (≤ 5) consultation offered prior to the delivery of the first cycle of IV chemotherapy.

• N = 47  
• MEAN AGE = 52.77 years (range = 24–76 years)
• MALES: 35%, FEMALES: 65%
• KEY DISEASE CHARACTERISTICS: Caregivers of chemotherapy-naïve patients with breast, colon, or lung cancer scheduled to begin IV chemotherapy; all patients aged 18 years or older
• OTHER KEY SAMPLE CHARACTERISTICS: Caregivers were nominated by patients as providing most support; aged greater than 18 years; married; spouse; and half were employed

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: London teaching hospital

• PHASE OF CARE: Active antitumor treatment

Two-phase, mixed-method, pilot randomized, controlled trial with a later purposive subsample of the Take Care group gaining variation in caregiver characteristics and data on intervention feasibility and acceptability (focus groups of six healthcare providers also served later purpose)

• Visual Analog Scale (VAS) for knowledge of chemotherapy and side effects 
• Supportive Care Needs Survey for Partners' and Caregivers' unmet needs (SCNS-P)
• Experience of care (investigator-designed 11-item Likert scale)
• Perceived confidence in supporting friend/relative (investigator-designed six-item numerical rating)
• General Health Questionnaire 12 (GHQ-12) for emotional well being

There were statistically significant improvements in intervention group caregiver knowledge of chemotherapy and side effects (all nine areas ≤ 0.012), their satisfaction with care in (five of seven items), and in the number of caregivers who felt they had the information they needed or that their informational needs had been met (p < 0.001). No difference between the intervention and control groups was demonstrated in emotional well-being or in caregivers' experience of care except for one item involving the time that staff members spent with care, which was higher for the intervention group (p = 0.014). Confidence in coping showed a trend towards significance after the intervention. In addition, focus group data showed that the intervention was feasible, acceptable, and useful.

The Take Care intervention for the caregivers of patients starting IV chemotherapy showed promise as an acceptable and feasible approach to support and educate caregivers.

• Small sample (< 100)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Findings not generalizable
• Other limitations/explanation: The five instruments used in study lacked reliability and validity information (three were developed by an investigator, not clear which author). The definition of feasibility and acceptability was not clear enough to aptly interpret findings. Some concern about intervention acceptability existed with the 41% participation refusal rate. Only 33% of caregivers who were invited to focus groups participated (four of 12). The caregiver convenience sample was 70% Caucasian British. Only one author analyzed the qualitative data, and it was unclear who moderated the group to avoid bias. It was unclear how the NHS in the United Kingtom may have influenced findings.

The Take Care intervention may provide an acceptable, useful, and feasible approach to meet the educational and support needs of the caregivers of patients receiving chemotherapy the first time. Additional studies reflecting methodologic rigor with United States population groups are warranted to determine if the intervention may be effective in improving caregiver knowledge of chemotherapy and side effects, meeting educational and support needs, and improving caregiver emotional well-being and role satisfaction.