NCT03032250 · REGISTRY CONDITION SEARCH

Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2023-01-09

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions

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outcome · POSTED

Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment

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outcome · POSTED

Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)

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outcome · POSTED

Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD)

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outcome · POSTED

Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)

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outcome · POSTED

Frequency of Intervention Modules Utilized Assessed by Caregiver Logs

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outcome · POSTED

Number of Participants in Agreement to Perform Interventions

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outcome · POSTED

Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate

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outcome · POSTED

Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR)

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outcome · POSTED

Self-efficacy in Coping With Cancer Caregiver Inventory

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outcome · POSTED

Salivary Cortisol Collection

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: CAREGIVERS: * Providing the majority of the informal (unpaid) care during radiation therapy for a patient meeting inclusion criteria and participating in study CARE-RECIPIENTS: * Has a new or recurrent American Joint Committee on Cancer (AJCC) stage I-IV squamous cell carcinoma of the upper aerodigestive tract (including lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, and larynx cancers) * Has planned external beam radiotherapy (+/- chemotherapy) for 6-7 weeks * Has an informal (unpaid) caregiver during radiation therapy who is participating in study Exclusion Criteria: * CAREGIVERS: Has a current cancer diagnosis * CAREGIVERS: Cannot read/communicate in English * CAREGIVERS: Have an endocrine disorder (e.g., diabetes and thyroid disorders), or is currently taking a steroid based medication will not be eligible to participate in the saliva portion of the study * CARE-RECIPIENTS: Cannot read/communicate in English
healthy Volunteers: true
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Other: Communication Intervention
Other: Watch video
Other: Module completion of the Prepare to Care kit
Other: Quality-of-Life Assessment
Other: Survey Administration
Other: Salivary cortisol collection
label
Group I Supportive Care (Prepare to Care kit)
type
EXPERIMENTAL
description
Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study
intervention Names
Other: Watch video
Other: Module completion of the Prepare to Care kit
Other: Quality-of-Life Assessment
Other: Survey Administration
Other: Salivary cortisol collection
label
Group II Control Group
type
EXPERIMENTAL

interventions

arm Group Labels
Group I Supportive Care (Prepare to Care kit)
description
Attend interventionist sessions
name
Communication Intervention
type
OTHER
arm Group Labels
Group I Supportive Care (Prepare to Care kit)
Group II Control Group
description
Watch video on a DVD
name
Watch video
other Names
Education for Intervention
Intervention by Education
Intervention through Education
Intervention, Educational
type
OTHER
arm Group Labels
Group I Supportive Care (Prepare to Care kit)
Group II Control Group
description
Complete modules of the Prepare to Care kit
name
Module completion of the Prepare to Care kit
other Names
Education for Intervention
Intervention by Education
Intervention through Education
Intervention, Educational
type
OTHER
arm Group Labels
Group I Supportive Care (Prepare to Care kit)
Group II Control Group
description
Ancillary studies
name
Quality-of-Life Assessment
other Names
Quality of Life Assessment
type
OTHER
arm Group Labels
Group I Supportive Care (Prepare to Care kit)
Group II Control Group
description
Ancillary studies
name
Survey Administration
type
OTHER
arm Group Labels
Group I Supportive Care (Prepare to Care kit)
Group II Control Group
description
Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
name
Salivary cortisol collection
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 35
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

description
For eligible caregivers only - collected three times a day (at awakening, 30 minutes post-awakening, and bedtime) for two consecutive days following T1 (start of radiation), T2 (end of radiation), and T3 (6 weeks post radiation). To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening response, area under the curve, and intra-individual cortisol variability). Investigators will use a mixed model to evaluate differences between the groups in these parameters at times T1 and T2 and T3
measure
Salivary Cortisol Collection
time Frame
Up to 1 year

primary Outcomes

description
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.
measure
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
time Frame
Six weeks post radiation therapy
description
38 patient/caregiver dyads agreed to participate, 22 months of recruitment, for accrual rate of 1.7 (caregiver) participants per month
measure
Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment
time Frame
Up to 1 year
description
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.
measure
Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)
time Frame
Baseline and following radiotherapy, assessed up to 1 year
description
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.
measure
Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD)
time Frame
Before and after radiotherapy, assessed up to 1 year
description
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.
measure
Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)
time Frame
Before and after radiotherapy, assessed up to 1 year
description
Data on intervention resources used and time spent using them based on caregivers in intervention group
measure
Frequency of Intervention Modules Utilized Assessed by Caregiver Logs
time Frame
Up to 1 year
description
Participation assessed by number of eligible participants who agreed to participate and complete study interventions.
measure
Number of Participants in Agreement to Perform Interventions
time Frame
Up to 1 year
measure
Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate
time Frame
Up to 1 year
description
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.
measure
Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR)
time Frame
At baseline and up to the end of radiotherapy, assessed up to 1 year
description
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.
measure
Self-efficacy in Coping With Cancer Caregiver Inventory
time Frame
At baseline and up to the end of radiotherapy, assessed up to 1 year

Full study description

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.
detailed Description: PRIMARY OBJECTIVES: I. To assess feasibility (accrual, participation, and retention) and acceptability of a supported self-management intervention for psycho-education and stress management skills building designed for informal caregivers (intervention group n=20; waitlist control group, n=20) of head and neck cancer (HNC) patients undergoing radiotherapy (RT). II. To obtain preliminary data on caregiver intermediate (self-efficacy for \[a\] coping with cancer and \[b\] abbreviated progressive muscle relaxation) and outcome variables (burden, psychological distress, quality of life) in intervention caregivers and waitlist control caregivers at the start of radiation (T1), end of radiation (T2), and 6-weeks post-radiation (T3). III. To compare intermediate (self-efficacy for (a) coping with cancer and (b) abbreviated progressive muscle relaxation) and outcome variables (burden, psychological distress, quality of life) between intervention caregivers and waitlist control caregivers at T1, T2, and T3. IV. To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Caregivers watch introduction video on a digital video disc (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. GROUP II: Caregivers receive educational intervention as in Group I but do not attend interventionist sessions.

Source references

references

citation
Nightingale C, Sterba KR, Levine B, Tooze JA, Greven K, Frizzell B, Hughes RT, Snavely A, Lesser GJ, Norona S, Pleasant K, Weaver KE. Feasibility and Acceptability of a Multi-Modality Self-Management Intervention for Head and Neck Cancer Caregivers: A Pilot Randomized Trial. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221098984. doi: 10.1177/15347354221098984.
pmid
35575280
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice