Cancer Parenting Program for the Enhancement of the Quality of Life of Patients With Advanced Cancer and Their Children

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 23 to 68 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

2 sites in 1 country.

About this study

Official title: Enhancing Connections-Palliative Care: A Cancer Parenting Program for Patients With Advanced Cancer and Their Children

Conditions

Parent-Child Relations, Cancer, Survivorship, Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Parent-Child Relation

Being tested

Group 1: Educational counseling intervention, Group II Active Comparator

Medical subject headings

Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Group 1: Educational counseling interventionBehavioural

  Also called EC-PC

  Enrolled parents received 5 telephone-delivered educational counseling interventions at 2-week intervals, the EC-PC Program.

• Group II Active ComparatorBehavioural

  Also called Control group

  Patients receive carefully selected educational booklet that discuss ways to talk about their cancer with their child and a scripted phone call from a trained phone counselor on study.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Treatment Efficacy Assessed by Parents' Mood-Center for Epidemiological Studies-Depression (CES-D)

   Depressed mood will be measured by the 20-item Center for Epidemiological Studies- Depression Scale (CES-D) (Radloff, 1977). The CES-D Scale measures the recent occurrence of symptoms of depression. For each symptom, the respondent indicates the frequency with which that symptom has occurred during the past week, from "rarely or none of the time (less than 1 day)" to "most or all of the time (5-7 days)." This measure has been well- accepted in both ill and non-ill samples. Internal consistency in three samples from the general population has been reported by Radloff, 1977, and ranged between .84 to .85. Validity is well- established, including its link to the broader concept of "distress" in cancer-related research (Benazon \& Coyne, 2000). The internal consistency reliability is 0.85 or higher (Benazon \& Coyne, 2000). Total score ranges from 0-60. Higher scores denote worse outcome. Clinical cut off for distress is 16 or higher.

   Measured: At 3 months post-baseline

2. Treatment Efficacy Assessed by Parents' Anxiety [Spielberger State-Trait Anxiety (STAI, State Scale)]

   State anxiety will be measured by the state component of the State-Trait Anxiety Inventory. This 20-item self-report questionnaire evaluates current feelings of apprehension, tension, nervousness, and worry. The respondent circles a response that best depicts their current feelings best. Response options range from [1 - Not at all] to [5 - Very much so]. Sample items include "I feel calm", I am tense." Higher scores denote greater anxiety. Internal consistency reliability is 0.90 or above in community and population samples [Edwards and Clarke, 2004]. Scale range: 20-80. Clinical cut off for distress is 40 or higher. Missing data imputation caused scores to be non-whole integers.

   Measured: At 3 months post-baseline

3. Parent's Confidence in Being Able to Talk With Her Child About the Child's Cancer-related Concerns (CASE Help Child Subscale)

   Parenting Self-efficacy: Measured by the Help Child subscale of the parent-reported cancer Self-efficacy Scale (CASE). The Help Child subscale (9 items) measures the parent's confidence in being able to talk with her child about the child's cancer-related concerns; e.g., "I can assist my child to talk out his/her worries about my cancer." Structured response options range from "Not at all confident" (1) to "Very confident." The internal consistency reliability The internal consistency reliabilities in the EC seminal trial with parents with early stage cancer was 0.97. Higher scores denote better outcome. Range of scores: 0-90. There is no known clinical cutoff score on this measure.

   Measured: At 3 months post-baseline

4. Parents' Skills in Helping Their Child Cope and Manage the Toll of the Parents' Cancer (Connecting and Coping Subscale)

   Parenting skills will be measured by the parent reported Parenting Skills Checklist: Connecting and Coping subscale developed by the study team and tested for reliability and validity in a 6-state randomized control trial (Lewis et al., 2015). The measure describes the observable interactional behaviors parents can use to assist their child disclose, discuss, and cope with the parent's cancer. The developmental-contextual model of parenting was the conceptual basis for the measure. An example item on the Connecting and Coping subscale includes, "I work with my child to help my child manage the child's stress related to my cancer." Range of subscale: 0-50. Higher scores reflect a better outcome. There is no clinical cut off score for parents' skills.

   Measured: At 3 months post-baseline

5. Child-Behavioral Emotional Functioning: Anxious/Depressed Score on the Child Behavioral Checklist (CBCL)

   The child's behavioral-emotional adjustment will be measured by 3 subscales: the Anxious/Depressed scores, Internalizing Problems score, and Externalizing Problems scores, all part of the Child Behavior Checklist. See specific subscale scores, entered separately below. Response options for all subscales range from 0 to 2 from "Not True (as far as you know)" to "Somewhat or Sometimes True" to "Very True or Often True." Higher scores denote worse outcomes. Range of scores for Internalizing and Externalizing Problems is 34-100 and 50-100 for the Anxious/Depressed score. Internal consistency reliabilities were established as 0.90 for the Internalizing score and 0.94 for the Externalizing score. For the current study, the CBCL form for 6-18 year-olds and its computer software were used. The theoretical range of scores on the Anxious/Depressed score is 50-100. The theoretical range of the Internalizing and Externalizing problems subscales are both 34-100.

   Measured: At 3 months post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted28 Jul 2022
2. Study start19 Jul 2022
3. Primary completion21 May 2025
4. Study completion15 Aug 2025

Why it stopped: Enrollment rates to the trial were lower than projected and anticipated.

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
• More trials run by University of WashingtonThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.