Metastatic Breast Cancer, Parenting
Conditions
Keywords
Parenting
Brief summary
This is a single-arm pilot study to evaluate the feasibility and acceptability of a novel psychosocial intervention to improve psychosocial outcomes for parents with advanced cancer and their co-parents. In this single-center study, we will recruit ten mothers with metastatic breast cancer and their co-parents as dyads (N=20) to participate in the Fathers and Mothers Invested in the Lives of their Youth (FAMILY) intervention. Patient and co-parent dyads will participate in 2-3 study visits with an intervention facilitator and a post-intervention feedback interview. Participants will also complete baseline and follow-up study surveys. The final products of this study will be the FAMILY intervention manual and training materials, and fidelity assessments.
Detailed description
Cancer is the leading disease-specific cause of early parental death in the United States and having dependent children worsens suffering for parents with advanced cancer and their families. The FAMILY intervention consists of manualized visits with a trained intervention facilitator and psychoeducation materials to help parents cope with cancer-related parenting concerns. The purpose of the intervention is to improve parenting concerns, emotional well-being, and end-of-life (EOL) preparation among participants. This study will evaluate whether a psychosocial intervention to reduce psychological distress and improve EOL preparation for mothers with metastatic breast cancer and their co-parents can be acceptable, feasible, and relevant to the target patient population. This study is needed in order to generate critical data to: (1) refine the intervention in preparation for a pilot efficacy randomized controlled trial (RCT); and to generate preliminary data demonstrating the feasibility and acceptability of core intervention components. The preliminary data will support future grant applications for a full-scale efficacy RCT.
Interventions
BEHAVIORALFAMILY Intervention
The FAMILY intervention involves 2-3 study visits with a specially-trained intervention facilitator. Study visits are manualized and complemented by patient education materials.
Sponsors
National Cancer Institute (NCI)
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Because this is a pilot study, all participant dyads will receive the same intervention and no blinding will take place.
Intervention model description
10 patient and co-parent dyads (20 participants in total) will participate in the pilot study to evaluate the feasibility and acceptability of the FAMILY intervention. Preliminary effects of the intervention will also be examined.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
for patients: * Be a woman with metastatic (stage IV) breast cancer who has either: (1) estrogen (ER), progesterone (PR), or HER2 receptor-negative cancer and disease progression beyond first line of therapy, or (2) ER, PR, or HER2 -positive cancer and disease progression beyond two lines of therapy; * A mother of at least one dependent child, defined as a child \<18 years of age who lives at least half-time in the home; * Be at least 18 years of age; * Adequate stamina to complete at least two study visits * Able to provide informed consent * Able to complete all study measures and visits in English; * Be willing to participate in study visits at the North Carolina Cancer Hospital (NCCH) if they live \>75 miles away from NCCH * Have an identified co-parent who is eligible and willing to participate in the study. Inclusion Criteria for Co-parents: * Be an adult man or woman who is both a partners or spouse of the patient and who would serve as the child(ren)'s primary caregiver if the patient were to become unavailable; * Able to provide informed consent; * Able to complete all study measures and visits in English; * Stated willingness to comply with all study procedures; and * Be at least 18 years of age.
Exclusion criteria
for patients and co-parents: * Unable to participate in study visits due to illiteracy, inability to speak English or other causes. * Live more than 75-miles away from the North Carolina Cancer Hospital (NCCH) and unable to attend study visits at NCCH (participants who live more than 75-miles away and can attend study visits at NCCH remain eligible for participation). * Unwilling to be audio-recorded during facilitated study visits and feedback interview.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Recruitment | Baseline | Assess how likely patient-co-parent dyads are to join the study by tracking the number of eligible dyads who participate in the study. |
| Acceptability of the Intervention | 42 Days | Acceptability of the intervention was defined as the number of participants who completed the study intervention. Participants' experience was assessed qualitatively, using post-intervention interviews. |
| Acceptability of the Intervention Measured by the Study Visit Assessment Form | 7 Days | The acceptability of the intervention was assessed through participants' satisfaction with the program. The Lyon Satisfaction questionnaire consists of 5-point Likert-type items assessing positive (six items) and negative (seven items) emotional reactions to the study visit. Responses were summed and reported for each subscale with higher scores meaning higher emotional reactions, and worse reactions. Positive subscale: 6-30 and negative subscale: 7-35. |
| Feasibility of Study Procedures | 14 Days | Feasibility of study procedures were assessed how likely patient-co-parent dyads are to join the study through tracking the number of eligible dyads who participate in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Change in Patient and Co-parent's Illness-related Communication | Baseline, 7 Days, 14 Days, 28 Days, 42 Days | The change in patient and co-parent's illness-related communication was measured by the Couples Illness Communication Scale (CICS). The CICS is a brief self-report measure of illness-related couple communication. The CICS consists of 4 items measured on a 5-point Likert-type scale. Total Score Range: 4-20, Higher is better. |
| Feasibility of Completion | Up to 42 Days | Feasibility of Completion was evaluated by tracking the number of dyads that complete the study visits and study assessments. Numbers reflect from Baseline through 42 days given a flexible duration of intervention. |
| Patient and Co-parent's Cancer-related Family Communication | Baseline, 7 Days, 14 Days, 28 Days, 42 Days | Patient and Co-Parent's Cancer-related Family Communication was assessed changes in the patient and co-parent's scores for a nine-item investigator-developed measure. The measure assesses participants' confidence and preparation to engage in communication about the impact of parental cancer on children. For the first 8 items, the score range is on a 4-point scale (1 to 4). The last item is graded on a 3-point scale (1 to 3). For all 9 items, higher is better. Due to the small sample size, each individual score item was reported. |
| Patient's Health-related Quality of Life | Baseline, 7 Days, 14 Days, 28 Days, 42 Days | Patient Health-related Quality of Life was assessed change in the patient's health-related quality of life measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal). The FACIT-Pal is a 46-item self-administered assessment of general HRQOL in cancer patients. It is graded on a 4-point scale and higher scores indicate better quality of life. Total Score Range: 0-184 Assess change in the patient's health-related quality of life measured by the FACIT-Pal; the FACIT-Pal is a 46-item self-administered assessment of general HRQOL in cancer patients. It is graded on a 4-point scale and higher scores indicate better quality of life. The numbers analyzed reflect all individuals who contributed data at each time point. |
| Emotional Well-being Measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal Care) Subscale | Baseline, 7 Days, 14 Days, 28 Days, 42 Days | Assess the change in patient's emotional well-being through the FACIT-Pal Care; a 6-item self-report assessment of emotional well-being that is widely used in palliative care research. Score range is 0-24, higher scores indicate better emotional well-being. |
| Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS) | Baseline, 7 Days, 14 Days, 28 Days, 42 Days | Assess the change in patient and co-parent's depression and anxiety symptom severity. The HADS consists of two 7-item subscales assessing depression and anxiety symptoms separately. Score range for each subscale is 0-21, higher scores indicate greater symptoms. |
| Parenting Concerns Measured by the Parenting Concerns Questionnaire-Advanced Disease (PCQ-AD) | Baseline, 7 Days, 14 Days, 28 Days, 42 Days | Assess the change in patient and co-parent's parenting concerns severity. The PCQ-AD is an investigator-adapted measure of parenting concerns measured on a 4-point scale. Total score range for the PCQ-AD is 0-3 with higher scores indicating greater distress. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 10/30/2019 through 01/25/2022 at one cancer center in North Carolina.
Pre-assignment details
A total of 15 subjects (8 patients and 7 co-parents) consented and were found eligible for the study.
Participants by arm
| Arm | Count |
|---|---|
| Patient Subjects who are diagnosed with cancer. | 8 |
| Co-parent Subjects who are spouses of patients with cancer. | 7 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | Patient | Total | Co-parent |
|---|---|---|---|
| Age, Continuous | 40.75 years STANDARD_DEVIATION 8.65 | 42.86 years STANDARD_DEVIATION 9.31 | 45.67 years STANDARD_DEVIATION 10.21 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 6 Participants | 12 Participants | 6 Participants |
| Region of Enrollment United States | 8 participants | 15 participants | 7 participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 7 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Acceptability of the Intervention
Acceptability of the intervention was defined as the number of participants who completed the study intervention. Participants' experience was assessed qualitatively, using post-intervention interviews.
Time frame: 42 Days
Population: The number of total participants who started the intervention and completed post-intervention semi-structured interview.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FAMILY | Acceptability of the Intervention | The patient and co-parent started the study. | 10 Participants |
| FAMILY | Acceptability of the Intervention | The patient and co-parent completed a post-intervention interview. | 7 Participants |
Primary
Acceptability of the Intervention Measured by the Study Visit Assessment Form
The acceptability of the intervention was assessed through participants' satisfaction with the program. The Lyon Satisfaction questionnaire consists of 5-point Likert-type items assessing positive (six items) and negative (seven items) emotional reactions to the study visit. Responses were summed and reported for each subscale with higher scores meaning higher emotional reactions, and worse reactions. Positive subscale: 6-30 and negative subscale: 7-35.
Time frame: 7 Days
Population: 10 Subjects completed the study visit assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMILY | Acceptability of the Intervention Measured by the Study Visit Assessment Form | Positive emotions | 26.6 score on a scale | Standard Deviation 5.3 |
| FAMILY | Acceptability of the Intervention Measured by the Study Visit Assessment Form | Negative emotions | 11.7 score on a scale | Standard Deviation 2.8 |
Primary
Feasibility of Recruitment
Assess how likely patient-co-parent dyads are to join the study by tracking the number of eligible dyads who participate in the study.
Time frame: Baseline
Population: All 18 participants/co-parents were approached by the study team.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FAMILY | Feasibility of Recruitment | Eligible | 9 Participants |
| FAMILY | Feasibility of Recruitment | Consented | 8 Participants |
| Co-parents | Feasibility of Recruitment | Eligible | 9 Participants |
| Co-parents | Feasibility of Recruitment | Consented | 7 Participants |
Primary
Feasibility of Study Procedures
Feasibility of study procedures were assessed how likely patient-co-parent dyads are to join the study through tracking the number of eligible dyads who participate in the study.
Time frame: 14 Days
Population: The number of participants (patient and co-parent) who started the intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FAMILY | Feasibility of Study Procedures | Started | 5 Participants |
| FAMILY | Feasibility of Study Procedures | Completed | 4 Participants |
| Co-parents | Feasibility of Study Procedures | Started | 5 Participants |
| Co-parents | Feasibility of Study Procedures | Completed | 3 Participants |
Secondary
Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS)
Assess the change in patient and co-parent's depression and anxiety symptom severity. The HADS consists of two 7-item subscales assessing depression and anxiety symptoms separately. Score range for each subscale is 0-21, higher scores indicate greater symptoms.
Time frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
Population: Numbers analyzed reflect participants at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMILY | Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS) | Baseline Anxiety | 8.6 score on a scale | Standard Deviation 2.8 |
| FAMILY | Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS) | Baseline Depression | 5.1 score on a scale | Standard Deviation 3.8 |
| FAMILY | Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS) | 7 Days Anxiety | 8.1 score on a scale | Standard Deviation 2.4 |
| FAMILY | Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS) | 7 Days Depression | 5.7 score on a scale | Standard Deviation 4.3 |
| FAMILY | Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS) | 14 Days Anxiety | 9.0 score on a scale | Standard Deviation 1.7 |
| FAMILY | Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS) | 14 Days Depression | 6.0 score on a scale | Standard Deviation 4.3 |
| FAMILY | Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS) | 28 Days Anxiety | 9.3 score on a scale | Standard Deviation 2.2 |
| FAMILY | Anxiety and Depression Symptoms Measured by the Hospital Anxiety and Depression Scale (HADS) | 28 Days Depression | 3.3 score on a scale | Standard Deviation 2.2 |
Secondary
Emotional Well-being Measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal Care) Subscale
Assess the change in patient's emotional well-being through the FACIT-Pal Care; a 6-item self-report assessment of emotional well-being that is widely used in palliative care research. Score range is 0-24, higher scores indicate better emotional well-being.
Time frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
Population: Baseline, patient participants only
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMILY | Emotional Well-being Measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal Care) Subscale | Baseline | 16.4 units on a scale | Standard Deviation 4.3 |
| FAMILY | Emotional Well-being Measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal Care) Subscale | 7 days | 18.0 units on a scale | Standard Deviation 4.5 |
| FAMILY | Emotional Well-being Measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal Care) Subscale | 14 days | 13.7 units on a scale | Standard Deviation 1.2 |
| FAMILY | Emotional Well-being Measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal Care) Subscale | 28 days | 20.5 units on a scale | Standard Deviation 2.1 |
Secondary
Feasibility of Completion
Feasibility of Completion was evaluated by tracking the number of dyads that complete the study visits and study assessments. Numbers reflect from Baseline through 42 days given a flexible duration of intervention.
Time frame: Up to 42 Days
Population: The number of participants (patient and co-parent) consented and completed study visits.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FAMILY | Feasibility of Completion | 28 days | 2 Participants |
| FAMILY | Feasibility of Completion | Baseline | 6 Participants |
| FAMILY | Feasibility of Completion | 7 days | 5 Participants |
| FAMILY | Feasibility of Completion | 14 days | 4 Participants |
| FAMILY | Feasibility of Completion | 42 days | 0 Participants |
| FAMILY | Feasibility of Completion | Enrolled | 8 Participants |
| Co-parents | Feasibility of Completion | 42 days | 0 Participants |
| Co-parents | Feasibility of Completion | Enrolled | 7 Participants |
| Co-parents | Feasibility of Completion | 14 days | 3 Participants |
| Co-parents | Feasibility of Completion | Baseline | 5 Participants |
| Co-parents | Feasibility of Completion | 28 days | 2 Participants |
| Co-parents | Feasibility of Completion | 7 days | 5 Participants |
Secondary
Parenting Concerns Measured by the Parenting Concerns Questionnaire-Advanced Disease (PCQ-AD)
Assess the change in patient and co-parent's parenting concerns severity. The PCQ-AD is an investigator-adapted measure of parenting concerns measured on a 4-point scale. Total score range for the PCQ-AD is 0-3 with higher scores indicating greater distress.
Time frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
Population: Number analyzed reflects the number of participants at each time point contributing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMILY | Parenting Concerns Measured by the Parenting Concerns Questionnaire-Advanced Disease (PCQ-AD) | Baseline | 1.8 score on a scale | Standard Deviation 0.6 |
| FAMILY | Parenting Concerns Measured by the Parenting Concerns Questionnaire-Advanced Disease (PCQ-AD) | 7 Days | 1.5 score on a scale | Standard Deviation 0.7 |
| FAMILY | Parenting Concerns Measured by the Parenting Concerns Questionnaire-Advanced Disease (PCQ-AD) | 14 Days | 1.5 score on a scale | Standard Deviation 0.6 |
| FAMILY | Parenting Concerns Measured by the Parenting Concerns Questionnaire-Advanced Disease (PCQ-AD) | 28 Days | 1.1 score on a scale | Standard Deviation 0.4 |
Secondary
Patient and Co-parent's Cancer-related Family Communication
Patient and Co-Parent's Cancer-related Family Communication was assessed changes in the patient and co-parent's scores for a nine-item investigator-developed measure. The measure assesses participants' confidence and preparation to engage in communication about the impact of parental cancer on children. For the first 8 items, the score range is on a 4-point scale (1 to 4). The last item is graded on a 3-point scale (1 to 3). For all 9 items, higher is better. Due to the small sample size, each individual score item was reported.
Time frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
Population: Numbers analyzed reflect all participants who contributed data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | Baseline - comfort talking with children | 2.8 score on a scale | Standard Deviation 1 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | Baseline - comfort talking with partner | 3.7 score on a scale | Standard Deviation 0.5 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | Baseline - comfort talking about children's future needs | 3.4 score on a scale | Standard Deviation 1 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | Baseline - prepared to talk with children | 2.7 score on a scale | Standard Deviation 0.9 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | Baseline - prepared to talk with partner | 3.5 score on a scale | Standard Deviation 0.7 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | Baseline - prepared to talk about children's future needs | 3.5 score on a scale | Standard Deviation 0.7 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | Baseline - understand partner | 1.4 score on a scale | Standard Deviation 0.7 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | Baseline - spending time with children | 3.6 score on a scale | Standard Deviation 1.4 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | Baseline - prior conversations with children | 1.9 score on a scale | Standard Deviation 1 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 7 Days - comfort talking with children | 2.6 score on a scale | Standard Deviation 0.8 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 7 Days - comfort talking with partner | 3.2 score on a scale | Standard Deviation 0.4 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 7 Days - comfort talking about children's future needs | 3.5 score on a scale | Standard Deviation 0.5 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 7 Days - prepared to talk with children | 2.5 score on a scale | Standard Deviation 1 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 7 Days - prepared to talk with partner | 3.3 score on a scale | Standard Deviation 0.5 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 7 Days - prepared to talk about children's future needs | 3.3 score on a scale | Standard Deviation 0.5 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 7 Days - understand partner | 1.4 score on a scale | Standard Deviation 0.5 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 7 Days - spending time with children | 4.6 score on a scale | Standard Deviation 0.7 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 7 Days - prior conversations with children | 2.0 score on a scale | Standard Deviation 0.9 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 14 Days - comfort talking with children | 3.0 score on a scale | Standard Deviation 1 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 14 Days - comfort talking with partner | 3.0 score on a scale | Standard Deviation 0.6 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 14 Days - comfort talking about children's future needs | 3.0 score on a scale | Standard Deviation 0.6 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 14 Days - prepared to talk with children | 3.0 score on a scale | Standard Deviation 0.6 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 14 Days - prepared to talk with partner | 3.3 score on a scale | Standard Deviation 0.5 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 14 Days - prepared to talk about children's future needs | 3.3 score on a scale | Standard Deviation 0.5 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 14 Days - understand partner | 1.1 score on a scale | Standard Deviation 0.4 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 14 Days - spending time with children | 4.1 score on a scale | Standard Deviation 0.7 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 14 Days - prior conversations with children | 2.1 score on a scale | Standard Deviation 0.9 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 28 Days - comfort talking with children | 3.0 score on a scale | Standard Deviation 0.8 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 28 Days - comfort talking with partner | 3.3 score on a scale | Standard Deviation 0.5 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 28 Days - comfort talking about children's future needs | 3.3 score on a scale | Standard Deviation 0.5 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 28 Days - prepared to talk with children | 3.0 score on a scale | Standard Deviation 0.8 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 28 Days - prepared to talk with partner | 3.0 score on a scale | Standard Deviation 1 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 28 Days - prepared to talk about children's future needs | 3.0 score on a scale | Standard Deviation 1 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 28 Days - understand partner | 1.5 score on a scale | Standard Deviation 1 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 28 Days - spending time with children | 4.5 score on a scale | Standard Deviation 0.6 |
| FAMILY | Patient and Co-parent's Cancer-related Family Communication | 28 Days - prior conversations with children | 2.0 score on a scale | Standard Deviation 1.2 |
Secondary
Patient's Health-related Quality of Life
Patient Health-related Quality of Life was assessed change in the patient's health-related quality of life measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal). The FACIT-Pal is a 46-item self-administered assessment of general HRQOL in cancer patients. It is graded on a 4-point scale and higher scores indicate better quality of life. Total Score Range: 0-184 Assess change in the patient's health-related quality of life measured by the FACIT-Pal; the FACIT-Pal is a 46-item self-administered assessment of general HRQOL in cancer patients. It is graded on a 4-point scale and higher scores indicate better quality of life. The numbers analyzed reflect all individuals who contributed data at each time point.
Time frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
Population: Only patient participants completed the measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMILY | Patient's Health-related Quality of Life | Baseline | 122.8 score on a scale | Standard Deviation 36.1 |
| FAMILY | Patient's Health-related Quality of Life | 7 Days | 122.8 score on a scale | Standard Deviation 44.4 |
| FAMILY | Patient's Health-related Quality of Life | 14 Days | 138.7 score on a scale | Standard Deviation 24.1 |
| FAMILY | Patient's Health-related Quality of Life | 28 Days | 162.5 score on a scale | Standard Deviation 0.7 |
Secondary
The Change in Patient and Co-parent's Illness-related Communication
The change in patient and co-parent's illness-related communication was measured by the Couples Illness Communication Scale (CICS). The CICS is a brief self-report measure of illness-related couple communication. The CICS consists of 4 items measured on a 5-point Likert-type scale. Total Score Range: 4-20, Higher is better.
Time frame: Baseline, 7 Days, 14 Days, 28 Days, 42 Days
Population: Numbers reflect participants at each time point given flexible duration of intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMILY | The Change in Patient and Co-parent's Illness-related Communication | Baseline | 12.5 score on a scale | Standard Deviation 3 |
| FAMILY | The Change in Patient and Co-parent's Illness-related Communication | 7 Days | 14.1 score on a scale | Standard Deviation 2.2 |
| FAMILY | The Change in Patient and Co-parent's Illness-related Communication | 28 Days | 14.3 score on a scale | Standard Deviation 4.4 |
| FAMILY | The Change in Patient and Co-parent's Illness-related Communication | 14 Days | 13.6 score on a scale | Standard Deviation 4.5 |