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NCT03032250 · OUTCOME

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

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Six weeks post radiation therapy

What was measured

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.

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 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

Reported measurements

Introductory DVD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I Supportive Care (Prepare to Care Kit)4Not reportedNot reportedNot reportedNot reported
Meetings with study interventionist
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I Supportive Care (Prepare to Care Kit)6Not reportedNot reportedNot reportedNot reported
Relaxation CD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I Supportive Care (Prepare to Care Kit)7Not reportedNot reportedNot reportedNot reported
Weekly text reminders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I Supportive Care (Prepare to Care Kit)6Not reportedNot reportedNot reportedNot reported
Weekly email reminders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I Supportive Care (Prepare to Care Kit)4Not reportedNot reportedNot reportedNot reported
Study website
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I Supportive Care (Prepare to Care Kit)0Not reportedNot reportedNot reportedNot reported
Clinic iPads
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I Supportive Care (Prepare to Care Kit)0Not reportedNot reportedNot reportedNot reported
Cancer Education workbook
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I Supportive Care (Prepare to Care Kit)9Not reportedNot reportedNot reportedNot reported
Utilizing Resources workbook
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I Supportive Care (Prepare to Care Kit)7Not reportedNot reportedNot reportedNot reported
Managing Time workbook
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I Supportive Care (Prepare to Care Kit)7Not reportedNot reportedNot reportedNot reported
Seeking/Accepting Support workbook
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I Supportive Care (Prepare to Care Kit)7Not reportedNot reportedNot reportedNot reported
Communicating with Others workbook
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I Supportive Care (Prepare to Care Kit)7Not reportedNot reportedNot reportedNot reported
Healthy Behaviors workbook
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I Supportive Care (Prepare to Care Kit)7Not reportedNot reportedNot reportedNot reported
Positive Coping workbook
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I Supportive Care (Prepare to Care Kit)7Not reportedNot reportedNot reportedNot reported
Muscle Relaxation workbook
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group I Supportive Care (Prepare to Care Kit)7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Introductory DVD
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Meetings with study interventionist
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Relaxation CD
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Weekly text reminders
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Weekly email reminders
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Study website
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Clinic iPads
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Cancer Education workbook
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Utilizing Resources workbook
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Managing Time workbook
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Seeking/Accepting Support workbook
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Communicating with Others workbook
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
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.
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)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Six weeks post radiation therapy
title
Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice