Pilot Optimization Trial of Decision Partnering Intervention for Advanced Cancer Family Caregivers

NCT03947606 | Completed

• 1 other identifier: IRB-#300003601
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this study is to pilot test, for the first time, an optimization trial approach to develop and refine the decision partnering skills of family caregivers of persons with newly-diagnosed advanced cancer. Using a 2x2x2 full factorial design, 40 family caregivers of persons with newly-diagnosed advanced cancer will be randomized to receive one or more nurse coach-delivered decision partnering training components, based on the Ottawa Decision Support Framework and Social Support Effectiveness Theory4: 1) psychoeducation on effective decision partnering principles (1 vs. 3 sessions); 2) decision partnering communication training (yes vs. no); and 3) Ottawa Decision Guide training (yes vs. no).

Conditions

Family Caregivers; Cancer

Keywords

Decision-making; Decisions; Multiphase Optimization Strategy; Factorial design

Outcome Measures

Primary Outcomes (2)

• Feasibility

  Proportion of caregiver participants who complete assigned intervention components and proportion of caregiver and patient participants who complete study-related assessments.

  Baseline to 24 weeks

• Acceptability

  Through qualitative interviews, caregiver participant reported experiences with the CASCADE intervention and trial procedures.

  Baseline to 24 weeks

Secondary Outcomes (3)

• Patient-reported positive decision influence using Rini's Decision Influence Scale

  12 and 24 weeks after baseline

• Patient mood using the Hospital Anxiety and Depression Scale

  12 and 24 weeks after baseline

• Caregiver mood using the Hospital Anxiety and Depression Scale

  12 and 24 weeks after baseline

Study Arms (8)

Basic social support + communication + Ottawa guide

EXPERIMENTAL

3 in-person/telephone weekly sessions on providing decision social support, tips for good communication, and decision support tools

Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)

Basic social support + communication

EXPERIMENTAL

2 in-person/telephone weekly sessions on providing decision social support and tips for good communication

Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)

Basic social support + Ottawa guide

EXPERIMENTAL

2 in-person/telephone weekly sessions on providing decision social support and decision support tools

Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)

Basic social support only

EXPERIMENTAL

1 in-person/telephone weekly session on providing decision social support

Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)

Advanced social support + communication + Ottawa guide

EXPERIMENTAL

5 in-person/telephone weekly sessions on providing decision social support, tips for good communication, and decision support tools

Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)

Advanced social support + communication

EXPERIMENTAL

4 in-person/telephone weekly sessions on providing decision social support and tips for good communication

Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)

Advanced social support + Ottawa guide

EXPERIMENTAL

4 in-person/telephone weekly sessions on providing decision social support and decision support tools

Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)

Advanced social support only

EXPERIMENTAL

3 in-person/telephone weekly sessions on providing decision social support

Behavioral: CASCADE (CAre Supporters Coached to be Adept DEcision partners)

Interventions

CASCADE (CAre Supporters Coached to be Adept DEcision partners) BEHAVIORAL

CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, nurse coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training.

Advanced social support + Ottawa guide; Advanced social support + communication; Advanced social support + communication + Ottawa guide; Advanced social support only; Basic social support + Ottawa guide; Basic social support + communication; Basic social support + communication + Ottawa guide; Basic social support only

Eligibility Criteria

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

You may qualify if:

• ≥18 years of age;
• Self-endorsing or identified by the patient as "a relative, friend, or partner that has a close relationship with you and who assists you with your medical decisions and who may or may not live in the same residence as you and who is not paid for their help";
• Caregivers will need to have an agreeable patient willing to participate in the study (for data collection only);
• English-speaking and able to complete baseline measures; and
• Stated willingness to comply with all study procedures and be available for the duration of the study.

You may not qualify if:

• \) Self-reported active severe mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse
• PATIENTS
• ≥18 years of age;
• Diagnosed within past 60-90 days of initial pre-screening with an advanced cancer, defined as metastatic and/or recurrent/progressive stage III/IV cancer, including brain, lung, breast, gynecologic, head and neck, gastrointestinal, genitourinary cancer, melanoma; and hematologic malignancies;
• English-speaking and able to complete baseline measures; and
• Stated willingness to comply with all study procedures and be available for the duration of the study.
• \) Medical record documentation of active severe mental illness (i.e., schizophrenia, bipolar disorder, or major depressive disorder), dementia, active suicidal ideation, uncorrected hearing loss, or active substance abuse.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35226, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data collectors and principal investigator will be blind to participant condition; participants will be instructed NOT to discuss their assignment with data collectors. Trials participants will know their intervention condition as will the nurse coach involved in delivering the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 2x2x2 full factorial pilot randomized trial

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 13, 2019
• Study Start: October 31, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: December 5, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)