Brief Summary

This pilot clinical trial studies how well Prepare to Care kit works in improving caregiver support in patients with stage I-IV head and neck cancer that is new or has come back. Prepare to Care kit may increase knowledge about head and neck cancer and enhance stress-management skills.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.9 years study duration

First Submitted

Initial submission to the registry

January 17, 2017

Completed

9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed

4 months until next milestone

Study Start

First participant enrolled

May 15, 2017

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2020

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

July 1, 2021

Completed

Last Updated

January 9, 2023

Status Verified

December 1, 2022

Enrollment Period

2.9 years

First QC Date

January 17, 2017

Results QC Date

April 23, 2021

Last Update Submit

December 14, 2022

Conditions

Outcome Measures

Primary Outcomes (10)

Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
10-item quantitative survey will be developed for study to assess how much caregivers liked different aspects of the intervention. Acceptability will be summarized quantitatively and qualitatively. These acceptability questions were asked only of caregivers in the intervention group - Group 1 Supportive Care (Prepare to Care Kit). All data is based on participants answering the acceptability questions as "Quite a Bit/Very Much Helpful" for the intervention materials. Not all participants answered this part of the outcome measure.
Six weeks post radiation therapy
Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment
38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month
Up to 1 year
Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)
21-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). The CRA has been tested in cancer caregivers; demonstrated validity and reliability. Minimum and maximum scoring scale: BASELINE: Scores for esteem 15-31; lack of family support 5-15, impact of finances 3-12, impact of schedule 12-23, impact of health 11-16). AFTER RADIOTHERAPY: Scores for esteem 20-31; lack of family support 9-17, impact of finances 7-11, impact of schedule 14-22, impact of health 12-17). The higher the score the more the item being assessed impacted the participant.
Baseline and following radiotherapy, assessed up to 1 year
Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD)
The score is the sum of the 20 questions. Possible scoring range is 0-60. A score of 16 points or more is considered depressed.
Before and after radiotherapy, assessed up to 1 year
Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)
35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). The Cqol-Canc has demonstrated validity and reliability. Minimum and maximum score at baseline is a range of 9-78 and after radiotherapy a range of 2-73. The higher the score the greater the level of change in the quality of life for participants.
Before and after radiotherapy, assessed up to 1 year
Frequency of Intervention Modules Utilized Assessed by Caregiver Logs
Data on intervention resources used and time spent using them based on caregivers in intervention group
Up to 1 year
Number of Participants in Agreement to Perform Interventions
Participation assessed by number of eligible participants who agreed to participate and complete study interventions.
Up to 1 year
Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate
Up to 1 year
Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR)
A 3-item instrument developed for study to evaluate self-efficacy in APMR. Minimum to maximum scores range from 3-27. Higher scores demonstrate higher self efficacy in participants.
At baseline and up to the end of radiotherapy, assessed up to 1 year
Self-efficacy in Coping With Cancer Caregiver Inventory
21-item instrument assessing caregivers' perceived self-efficacy for coping with cancer (managing medical information, caring for care recipient, caring for oneself, managing difficult interactions/emotions); demonstrated validity and reliability. Minimum and maximum scores range from 10-63. Higher scores indicate higher self-efficacy in coping with cancer from the participants.
At baseline and up to the end of radiotherapy, assessed up to 1 year

Other Outcomes (1)

Salivary Cortisol Collection
Up to 1 year

Study Arms (2)

Group I Supportive Care (Prepare to Care kit)

EXPERIMENTAL

Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly.

Other: Communication InterventionOther: Watch videoOther: Module completion of the Prepare to Care kitOther: Quality-of-Life AssessmentOther: Survey AdministrationOther: Salivary cortisol collection

Group II Control Group

EXPERIMENTAL

Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study

Other: Watch videoOther: Module completion of the Prepare to Care kitOther: Quality-of-Life AssessmentOther: Survey AdministrationOther: Salivary cortisol collection

Interventions

Communication InterventionOTHER

Attend interventionist sessions

Group I Supportive Care (Prepare to Care kit)

Watch videoOTHER

Watch video on a DVD

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational