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| ID | Type | Description | Link |
|---|---|---|---|
| 5K07CA218167-02 | U.S. NIH Grant/Contract | View source |
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The study was stopped prematurely due to difficulty meeting accrual and retention goals, exacerbated by the COVID-19 pandemic.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAMILY | Experimental | Patient-co-parent dyads will participate in the FAMILY intervention in-person. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAMILY Intervention | Behavioral | The FAMILY intervention involves 2-3 study visits with a specially-trained intervention facilitator. Study visits are manualized and complemented by patient education materials. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 42 Days |
| 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. | 7 Days |
| 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. | 14 Days |
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 42 Days |
| Emotional Well-being Measured by the Functional Assessment of Chronic Illness Therapy - Palliative Care (FACIT-Pal Care) Subscale |
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Inclusion Criteria for patients:
Inclusion Criteria for Co-parents:
Exclusion Criteria for patients and co-parents:
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| Name | Affiliation | Role |
|---|---|---|
| Zev M Nakamura, MD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| Label | URL |
|---|---|
| UNC Lineberger Comprehensive Cancer Center Clinical Trials | View source |
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A total of 15 subjects (8 patients and 7 co-parents) consented and were found eligible for the study.
Participants were recruited from 10/30/2019 through 01/25/2022 at one cancer center in North Carolina.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients | Subjects who are diagnosed with cancer. |
| FG001 | Co-parents | Subjects who are spouses of patients with cancer. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Eight patients and 7 co-parents consented.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient | Subjects who are diagnosed with cancer. |
| BG001 | Co-parent | Subjects who are spouses of patients with cancer. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The number of total participants who started the intervention and completed post-intervention semi-structured interview. | Posted | Count of Participants | Participants | 42 Days |
|
Not available. The protocol does not require adverse event assessment.
The protocol does not require adverse event assessment. Adverse Event Data was not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FAMILY | Patient-co-parent dyads will participate in the FAMILY intervention in-person. FAMILY 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. |
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Early termination due to COVID-19 pandemic limiting research enrollment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zev Nakamura, MD | University of North Carolina at Chapel Hill | 984-974-3829 | zev_nakamura@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2020 | Apr 16, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 14, 2020 | Apr 13, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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.
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Because this is a pilot study, all participant dyads will receive the same intervention and no blinding will take place.
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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. |
| Baseline, 7 Days, 14 Days, 28 Days, 42 Days |
| 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. | Baseline, 7 Days, 14 Days, 28 Days, 42 Days |
| 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. | Baseline, 7 Days, 14 Days, 28 Days, 42 Days |
| 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. | Baseline, 7 Days, 14 Days, 28 Days, 42 Days |
| 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. | Baseline, 7 Days, 14 Days, 28 Days, 42 Days |
| 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. | Baseline, 7 Days, 14 Days, 28 Days, 42 Days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| 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. | 10 Subjects completed the study visit assessment | Posted | Mean | Standard Deviation | score on a scale | 7 Days |
|
|
|
| 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. | The number of participants (patient and co-parent) who started the intervention. | Posted | Count of Participants | Participants | 14 Days |
|
|
|
| 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. | All 18 participants/co-parents were approached by the study team. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 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. | The number of participants (patient and co-parent) consented and completed study visits. | Posted | Count of Participants | Participants | Up to 42 Days |
|
|
|
| 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. | Baseline, patient participants only | Posted | Mean | Standard Deviation | units on a scale | Baseline, 7 Days, 14 Days, 28 Days, 42 Days |
|
|
|
| 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. | Numbers analyzed reflect participants at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 Days, 14 Days, 28 Days, 42 Days |
|
|
|
| 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. | Number analyzed reflects the number of participants at each time point contributing data. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 Days, 14 Days, 28 Days, 42 Days |
|
|
|
| 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. | Numbers reflect participants at each time point given flexible duration of intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 Days, 14 Days, 28 Days, 42 Days |
|
|
|
| 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. | Only patient participants completed the measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 Days, 14 Days, 28 Days, 42 Days |
|
|
|
| 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. | Numbers analyzed reflect all participants who contributed data at each time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 7 Days, 14 Days, 28 Days, 42 Days |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| 7 days |
|
| 14 days |
|
| 28 days |
|
| 42 days |
|
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| 14 days |
|
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| 28 days |
|
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| 42 days |
|
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| 7 Days Anxiety |
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| 7 Days Depression |
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| 14 Days Anxiety |
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| 14 Days Depression |
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| 28 Days Anxiety |
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| 28 Days Depression |
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| 42 Days Anxiety |
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| 42 Days Depression |
|
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| 14 Days |
|
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| 28 Days |
|
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| 42 Days |
|
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| 14 Days |
|
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| 28 Days |
|
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| 42 Days |
|
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| 14 Days |
|
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| 28 Days |
|
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| 42 Days |
|
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| Baseline - comfort talking about children's future needs |
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| Baseline - prepared to talk with children |
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| Baseline - prepared to talk with partner |
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| Baseline - prepared to talk about children's future needs |
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| Baseline - understand partner |
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| Baseline - spending time with children |
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| Baseline - prior conversations with children |
|
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| 7 Days - comfort talking with children |
|
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| 7 Days - comfort talking with partner |
|
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| 7 Days - comfort talking about children's future needs |
|
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| 7 Days - prepared to talk with children |
|
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| 7 Days - prepared to talk with partner |
|
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| 7 Days - prepared to talk about children's future needs |
|
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| 7 Days - understand partner |
|
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| 7 Days - spending time with children |
|
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| 7 Days - prior conversations with children |
|
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| 14 Days - comfort talking with children |
|
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| 14 Days - comfort talking with partner |
|
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| 14 Days - comfort talking about children's future needs |
|
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| 14 Days - prepared to talk with children |
|
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| 14 Days - prepared to talk with partner |
|
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| 14 Days - prepared to talk about children's future needs |
|
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| 14 Days - understand partner |
|
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| 14 Days - spending time with children |
|
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| 14 Days - prior conversations with children |
|
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| 28 Days - comfort talking with children |
|
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| 28 Days - comfort talking with partner |
|
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| 28 Days - comfort talking about children's future needs |
|
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| 28 Days - prepared to talk with children |
|
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| 28 Days - prepared to talk with partner |
|
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| 28 Days - prepared to talk about children's future needs |
|
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| 28 Days - understand partner |
|
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| 28 Days - spending time with children |
|
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| 28 Days - prior conversations with children |
|
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| 42 Days - comfort talking with children |
|
| 42 Days - comfort talking with partner |
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| 42 Days - comfort talking about children's future needs |
|
| 42 Days - prepared to talk with children |
|
| 42 Days - prepared to talk with partner |
|
| 42 Days - prepared to talk about children's future needs |
|
| 42 Days - understand partner |
|
| 42 Days - spending time with children |
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| 42 Days - prior conversations with children |
|