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NCT03032250 · OUTCOME

Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR)

Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer · Source last updated 2023-01-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
At baseline and up to the end of radiotherapy, assessed up to 1 year

What was measured

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.

Groups in this outcome

Group I Supportive Care (Prepare to Care Kit)

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. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: 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.

Group II No Interventionist Sessions

Caregivers receive educational intervention as in Group I but do not attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: 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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Group I Supportive Care (Prepare to Care Kit)17
Group II No Interventionist Sessions18

Reported measurements

At baseline
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group I Supportive Care (Prepare to Care Kit)11.886.53Not reportedNot reportedNot reported
Group II No Interventionist Sessions13.335.36Not reportedNot reportedNot reported
After radiotherapy
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group I Supportive Care (Prepare to Care Kit)16.082.68Not reportedNot reportedNot reported
Group II No Interventionist Sessions12.195.59Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.53
        value
        11.88
      2. group Id
        OG001
        spread
        5.36
        value
        13.33
    title
    At baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.68
        value
        16.08
      2. group Id
        OG001
        spread
        5.59
        value
        12.19
    title
    After radiotherapy
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      18
    units
    Participants
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.
dispersion Type
Standard Deviation
groups
  1. 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. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: 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.
    id
    OG000
    title
    Group I Supportive Care (Prepare to Care Kit)
  2. description
    Caregivers receive educational intervention as in Group I but do not attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: 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.
    id
    OG001
    title
    Group II No Interventionist Sessions
param Type
MEAN
reporting Status
POSTED
time Frame
At baseline and up to the end of radiotherapy, assessed up to 1 year
title
Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR)
type
PRIMARY
unit Of Measure
score on a scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice