Kræftforældreprogram til forbedring af livskvaliteten for patienter med avanceret kræft og deres børn (EC-PC)

Patients receive the 5-session EC-PC program bi-weekly with a patient educator about ways to help them talk to and support their child.

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

• EC-PC

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.

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.

• Kontrolgruppe

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.

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.

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.

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.

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.

Self-report quantitative scale of patient's reported symptoms. BUT this was assessed as a potential covariate in the efficacy analysis and was used as such. It is not a primary nor a secondary outcome. Scores range from 0-4 with higher scores denoting greater psychological symptoms. There is no known clinical cut off score.