A Pilot Study on the Implementation of the WLS-Cancer Care Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Duke University
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Feasibility of recruitment of dyads for the WLSCC Intervention
Study Overview
Brief Summary
The purpose of the pilot is to test the feasibility of developing and implementing the Williams LifeSkills Cancer Care (WLSCC) and examining its preliminary impact on caregiver well-being and patient well-being. The study is a two-arm randomized intervention pilot (WLSCC vs. Usual Care [UC]) with data collection at baseline, immediately after training, and 2 weeks after completing the training. Study setting is at the breast and thoracic cancer clinics at the Duke Cancer Clinic. A total of 40 cancer patients (20 breast cancer patients and 20 lung cancer patients) and their caregivers (for a total N of 80) will be recruited for the pilot. The WLSCC will involve six 30-minute phone sessions and will encompass the application of 10 psychosocial skills within the context of cancer caregiving. Descriptive statistics will be used to detail recruitment/retention rate, fidelity rate, and the baseline demographic and clinical characteristics for the total sample and each group. Plots of the individual trajectories (within-person scores over time) will be used to identify the pattern(s) of change over time, and assess between-person variability in baseline values (intercepts) and trajectories (slopes). This study carries minimal risk to study participation.
Detailed Description
The pilot's specific aims are to:
- Test the feasibility of (a) recruiting lung and breast cancer patients and their caregivers (hereafter, "dyads) at the Duke Cancer Center (DCC) outpatient clinic; (b) training interventionists to deliver the WLSCC protocol; (c) delivering the WLSCC protocol by phone.
- Examine the immediate and two-week impact of the WLSCC on caregiver quality of life, anxiety and depression, caregiving preparedness, and social support as well as patient's well-being (Functional Assessment of Cancer Therapy.
Design and Procedures The pilot is two-arm randomized intervention pilot (WLSCC vs. Usual Care [UC]) with data collection at baseline (T1), immediately after training (T2), and 2 weeks after completing the training (T3). Caregivers will have an option to receive the WLCCC protocol, should they wish, after the data collection period. A stratified randomization will be conducted with stratifying variable being type of cancer and the block size will be 2.
The pilot setting is at the breast and thoracic cancer clinics at the DCC, Durham, NC. The WLSCC will involve approximately six 30-minute phone sessions between the caregiver and interventionist. The six calls will be delivered within three weeks of consent and will use intervention scripts for standardization of delivery.
The training will use the WLS format to assess issues and discuss strategies for cancer care including caregiver stress management. The context of discussion will be tailored by using the cancer issues endorsed by the cancer patient at baseline data collection. In delivering the interactive WLSCC training, the interventionist will preface each session by stating that the protocol is designed to enable them to cope more effectively with demanding caregiving situations and stressful life situations, to improve their relationships with others, and to increase the proportion of positive thoughts and feelings in their daily lives. The interventionist will frequently prompt the caregiver to raise questions that pertain to their situation (using cancer symptoms endorsed by cancer patient at baseline survey). At the end of each telephone session, the interventionist will request for the caregiver to complete log entries to provide an opportunity to reflect or put into action the WLSCC psychosocial skills taught in each session.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients are those with a confirmed medical diagnosis of breast or thoracic cancer regardless of stage and followed at DCC for management.
- •The cancer diagnosis should have been made less than a year from the next scheduled appointment to the DCC.
- •The caregiver is defined as unpaid individuals involved in assisting the cancer patient with activities of daily living and/or medical tasks.
- •Patients and caregivers must be able to hear, read, and write in English; oriented to place, person, and time; and have an active telephone service, either cellular or landline.
Exclusion Criteria
- •Excluding patients and caregivers who are less than 18 years of age
Arms & Interventions
WLSCC Intervention
Williams LifeSkills framework on stress management and cancer care
Intervention: WLSCC (Behavioral)
Usual Care
No intervention is provided
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
Feasibility of recruitment of dyads for the WLSCC Intervention
Time Frame: 6 months
Feasibility of recruiting as measured by the number of dyads approached per clinic visit
Feasibility of agreeing to participate in the WLSCC study
Time Frame: 6 months
Feasibility of recruiting as measured by the number of yes vs no to study participation
Feasibility of participating in phone calls for the study
Time Frame: 6 months
Feasibility of recruiting as measured by the rate of participation in phone calls
Feasibility of recruitment and completion of measures
Time Frame: 6 months
Feasibility of recruiting as measured by the completion of outcome measures including baseline demographics (please see below under secondary outcome measures for list of outcome measures)
Feasibility of recruitment longevity for the WLSCC Intervention
Time Frame: 6 months
Feasibility of recruiting as measured by the attrition rate at the end of data collection
Feasibility of training interventionist to deliver the WLSCC Intervention
Time Frame: 4 weeks
Feasibility of interventionist training as measured by the number of hours required to prepare the interventionists
Fidelity to the intervention protocol
Time Frame: 6 months
Fidelity rate as measured by the fidelity of intervention checklist
Feasibility of delivery of the WLSCC protocol by phone
Time Frame: 3 weeks
Feasibility of delivering the WLSCC protocol by phone as measured by the rate of participation in phone calls
Feasibility of delivery duration of the WLSCC protocol by phone
Time Frame: 3 weeks
Feasibility of delivering the WLSCC protocol by phone as measured by the duration of each phone call
Feasibility of recruitment for the WLSCC study for control group
Time Frame: 6 months
Feasibility of recruiting as measured by the number of caregivers in the usual care who elect to receive the WLSCC protocol
Secondary Outcomes
- Cancer Caregiver Quality of Life [CQOLC](15 minutes)
- Hospital Anxiety and Depression Scale (HADS)(5 minutes)
- Preparedness in Caregiving(5 minutes)
- Multidimensional Scale of Perceived Social Support(5 minutes)
- Functional Assessment of Cancer Therapy [FACT-G](15 minutes)