Cancer Clinical Trial
Official title:
A Pilot Study on the Implementation of the WLS-Cancer Care Protocol
Verified date | May 2017 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 7 |
Est. completion date | August 30, 2017 |
Est. primary completion date | August 30, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke Cancer Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of recruitment of dyads for the WLSCC Intervention | Feasibility of recruiting as measured by the number of dyads approached per clinic visit | 6 months | |
Primary | Feasibility of agreeing to participate in the WLSCC study | Feasibility of recruiting as measured by the number of yes vs no to study participation | 6 months | |
Primary | Feasibility of participating in phone calls for the study | Feasibility of recruiting as measured by the rate of participation in phone calls | 6 months | |
Primary | Feasibility of recruitment and completion of measures | 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) | 6 months | |
Primary | Feasibility of recruitment longevity for the WLSCC Intervention | Feasibility of recruiting as measured by the attrition rate at the end of data collection | 6 months | |
Primary | Feasibility of recruitment for the WLSCC study for control group | Feasibility of recruiting as measured by the number of caregivers in the usual care who elect to receive the WLSCC protocol | 6 months | |
Primary | Feasibility of training interventionist to deliver the WLSCC Intervention | Feasibility of interventionist training as measured by the number of hours required to prepare the interventionists | 4 weeks | |
Primary | Fidelity to the intervention protocol | Fidelity rate as measured by the fidelity of intervention checklist | 6 months | |
Primary | Feasibility of delivery of the WLSCC protocol by phone | Feasibility of delivering the WLSCC protocol by phone as measured by the rate of participation in phone calls | 3 weeks | |
Primary | Feasibility of delivery duration of the WLSCC protocol by phone | Feasibility of delivering the WLSCC protocol by phone as measured by the duration of each phone call | 3 weeks | |
Secondary | Cancer Caregiver Quality of Life [CQOLC] | 35 items - 5-pt Likert scale; Sum of all item scores; higher scores mean better quality of life | 15 minutes | |
Secondary | Hospital Anxiety and Depression Scale (HADS) | 7 on anxiety and 7 on depression; Sum of item scores on anxiety and depression; 11 and 21 "cases", 8 and 10 "borderline cases", and 0 and 7 as "non-cases" | 5 minutes | |
Secondary | Preparedness in Caregiving | 8 items, 5-pt Likert scale (0 - 4); Sum of item scores divide by number of items; higher total score denotes higher preparedness | 5 minutes | |
Secondary | Multidimensional Scale of Perceived Social Support | 7 pt Likert scale; Sum of item scores, then divide by number of items; higher score denotes higher perceived support | 5 minutes | |
Secondary | Functional Assessment of Cancer Therapy [FACT-G] | 27 items, 5-point Likert scale; Sum of subscale scores; higher score, the better quality of life | 15 minutes |
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