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Williams LifeSkills - Cancer Caregiver Intervention

NCT03174626 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2017-12-29

No results posted yet for this study

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

Interventions

BEHAVIORAL

WLSCC

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.

OTHER

Usual Care

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

Sponsors & Collaborators

Principal Investigators

  • Cristina C Hendrix, DNS, GNP-BC, FAAN · Duke University School of Nursing

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-03
Primary Completion
2017-08-30
Completion
2017-08-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03174626 on ClinicalTrials.gov