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NCT03032250 · OUTCOME

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

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
Before and after radiotherapy, assessed up to 1 year

What was measured

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.

Analysis population: Not all participants completed this intervention after radiotherapy timeframe indicated for this 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 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

Score at baseline

Analysis denominator · Participants

GroupSource count
Group I Supportive Care (Prepare to Care Kit)17
Group II No Interventionist Sessions18
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group I Supportive Care (Prepare to Care Kit)19.7113.05Not reportedNot reportedNot reported
Group II No Interventionist Sessions19.2812.97Not reportedNot reportedNot reported
Score after radiotherapy

Analysis denominator · Participants

GroupSource count
Group I Supportive Care (Prepare to Care Kit)12
Group II No Interventionist Sessions16
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group I Supportive Care (Prepare to Care Kit)19.0015.66Not reportedNot reportedNot reported
Group II No Interventionist Sessions13.588.65Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.05
        value
        19.71
      2. group Id
        OG001
        spread
        12.97
        value
        19.28
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    Score at baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.66
        value
        19.00
      2. group Id
        OG001
        spread
        8.65
        value
        13.58
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        16
      units
      Participants
    title
    Score after radiotherapy
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      18
    units
    Participants
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.
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
population Description
Not all participants completed this intervention after radiotherapy timeframe indicated for this outcome measure
reporting Status
POSTED
time Frame
Before and after radiotherapy, assessed up to 1 year
title
Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD)
type
PRIMARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice