Williams LifeSkills - Cancer Caregiver Intervention

NCT03174626 | Completed DMC

• 1 other identifier: Pro00079526
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

caregiver; stress management

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• Feasibility of participating in phone calls for the study

  Feasibility of recruiting as measured by the rate of participation in phone calls

  6 months

• 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

• 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

• 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

• 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

• Fidelity to the intervention protocol

  Fidelity rate as measured by the fidelity of intervention checklist

  6 months

• 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

• 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 Outcomes (5)

• 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

Study Arms (2)

WLSCC Intervention

EXPERIMENTAL

Williams LifeSkills framework on stress management and cancer care

Behavioral: WLSCC

Usual Care

OTHER

No intervention is provided

Other: Usual Care

Interventions

WLSCC BEHAVIORAL

Briefly, WLSCC contents are as follows: Psychosocial skill 1: Increase objectivity and awareness of thoughts and feelings in a distressing situation and learning the technique of a log entry; Psychosocial skill 2: Evaluate the situation to decide whether to change one's reactions or to take actions; Psychosocial skill 3: Increase the positive and the sense of meaning in your life; Psychosocial skill 4: Deflection strategies; Psychosocial skill 5: Take action when action is called for; Psychosocial skill 6: Assertion; Psychosocial skill 7: Saying "No"; Psychosocial skill 8 : Communication; Psychosocial skill 9: Become a better listener; Psychosocial skill 10: Empathy.

WLSCC Intervention

Usual Care OTHER

No training provided. After data collection period is over, participants have the option to receive the WLSCC training

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Excluding patients and caregivers who are less than 18 years of age

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Cristina C Hendrix, DNS, GNP-BC, FAAN

  Duke University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 2, 2017
• Study Start: May 3, 2017
• Primary Completion: August 30, 2017
• Study Completion: August 30, 2017
• Last Updated: December 29, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)