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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-05520 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| FHIRB0020936 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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This clinical trial studies whether telephone-based coaching sessions, Talking About Cancer (TAC), work to improve engagement in advance care planning (ACP) in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and their support person. Participation in ACP, which includes having end of life (EOL) care conversations and completing advance directives (e.g., living will, health care proxy, do not resuscitate order), improves quality EOL care. Despite this, less than half of patients with advanced cancer have EOL care conversations or complete advance directives. TAC coaching sessions are delivered by a social worker over the phone. They are designed to help patients and their support person communicate about ACP, manage the distress these conversations can cause, and participate in the process of ACP with a clear action plan of having goals-of-care conversations and completing advance directives. This may be an effective way to improve ACP participation in advanced cancer patients and their support person.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants attend Talking About Cancer (TAC) telephone-based coaching sessions (2 sessions) designed to support participants in communicating about advance care planning (ACP), managing distress around ACP conversations, engaging in the process of ACP, and completing advance directives over 45-60 minutes each once a week (QW) for 2 weeks.
ARM II: Participants receive an ACP brochure/handout on study.
After completion of study intervention, participants are followed up at 6- and 12-weeks post-randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (TAC sessions) | Experimental | Participants attend Talking About Cancer (TAC) telephone-based coaching sessions (2 sessions) designed to support participants in communicating about advance care planning (ACP), managing distress around ACP conversations, engaging in the process of ACP, and completing advance directives over 45-60 minutes each once a week (QW) for 2 weeks. |
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| Arm II (enhanced usual care) | Active Comparator | Participants receive an ACP brochure/handout on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supportive Care | Other | Attend TAC telephone-based coaching sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| Enrollment rate (Feasibility) | Feasibility will be examined using enrollment rates. Feasibility cutoffs will be based on prior research and include the following: ≥ 50% of eligible participants will enroll in the study. Low rates of enrollment, including missing data, will indicate low feasibility. | At 6-weeks post-randomization |
| Intervention session completion rate (Feasibility) | Feasibility will be examined using enrollment and intervention completion rates as outcomes. Feasibility cutoffs will be based on prior research and include the following: ≥ 75% of Talking About Cancer sessions will be delivered with fidelity. | At 6-weeks post-randomization |
| Acceptability of Intervention Measure (AIM) score (Acceptability) | To analyze intervention acceptability, will examine the median score for the AIM measure, with a median of >= 4 indicating acceptability (on a 5-point Likert scale where 4=Agree and 5=Completely agree and higher scores indicate higher levels of acceptability). | At 6-weeks post-randomization |
| Completion rate of study assessments (Feasibility of collecting primary and secondary outcomes) | Feasibility of the study collection procedures will be examined using study-related assessment completion rates and includes the following: ≥ 50% of enrolled patients will adhere to and complete assigned intervention components and study-related assessments. | At baseline, 6-weeks post- randomization, and 12-weeks post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of advance directives | Completion of advance directives will be assessed with questions that ask patients (caregivers) whether the patient has completed a do not resuscitate (DNR) order, living will or identified a health care proxy. This item is scored as having not advance directives (0) to all advance directives completed (3). In addition to the primary outcome of advance directives (0 to 3 score), will also examine each outcome separately (e.g., yes/no to completing a health care proxy) as secondary measures. Descriptive statistics will be run, including means and standard deviations for continuous data and frequencies and proportions for categorical data. Bivariate correlations will be run between demographics and clinical characteristics to determine if any are associated with the primary outcome at baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Shen, PhD | Contact | 206-667-4172 | mshen2@fredhutch.org |
| Name | Affiliation | Role |
|---|---|---|
| Megan Shen, PhD | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Regional Cancer Partnership | Recruiting | Everett | Washington | 98201 | United States |
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The study project coordinator will oversee randomization and the research coordinator conducting assessments will remain blind to the condition to which the participant is assigned.
| Telephone-Based Intervention | Behavioral | Attend TAC telephone-based coaching sessions |
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| Survey Administration | Other | Ancillary studies |
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| Educational Intervention | Other | Receive an ACP brochure/handout |
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| At baseline, 6-weeks post-randomization, and 12-weeks post-randomization |
| Completion of do not resuscitate (DNR) order | Completion of advance directives will be assessed with questions that ask patients (caregivers) whether the patient has completed a DNR order. This item is scored as having not advance directives (0) to all advance directives completed (3). In addition to the primary outcome of advance directives (0 to 3 score), will also examine each outcome separately (e.g., yes/no to completing a health care proxy) as secondary measures. Descriptive statistics will be run, including means and standard deviations for continuous data and frequencies and proportions for categorical data. | At baseline, 6-weeks post-randomization, 12-weeks post-randomization |
| Completion of living will | Completion of advance directives will be assessed with questions that ask patients (caregivers) whether the patient has completed a living will. This item is scored as having not advance directives (0) to all advance directives completed (3). In addition to the primary outcome of advance directives (0 to 3 score), will also examine each outcome separately (e.g., yes/no to completing a health care proxy) as secondary measures. Descriptive statistics will be run, including means and standard deviations for continuous data and frequencies and proportions for categorical data. | At baseline, 6-weeks post-randomization, and 12-weeks randomization |
| Identification of a health care proxy | Completion of advance directives will be assessed with questions that ask patients (caregivers) whether the patient has identified a health care proxy. This item is scored as having not advance directives (0) to all advance directives completed (3). In addition to the primary outcome of advance directives (0 to 3 score), will also examine each outcome separately (e.g., yes/no to completing a health care proxy) as secondary measures. Descriptive statistics will be run, including means and standard deviations for continuous data and frequencies and proportions for categorical data. | At baseline, 6-weeks post-randomization, and 12-weeks post-randomization |
| Advance care planning (ACP) conversations | Will be assessed with the previously utilized 8-item measure of discussing end-of-life care (e.g., goals of care conversation), living will, health care proxy and DNR orders with doctor(s) and family members/loved ones. Descriptive statistics will be run, including means and standard deviations for continuous data and frequencies and proportions for categorical data. | At baseline, 6-weeks post-randomization, and 12-weeks post-randomization |
| Level of engagement in ACP | Will be measured using the reliable and valid Advance Care Planning Engagement Survey: Action Measures. It is an 18-item measure assessing domains of decision maker, quality of life, flexibility, and asking questions about treatment and ACP (yes/no). Descriptive statistics will be run, including means and standard deviations for continuous data and frequencies and proportions for categorical data. | At baseline, 6-weeks post-randomization, and 12-weeks post-randomization |
| Readiness to engage in ACP | Will be assessed using the previously developed and validated questionnaire, the Advance Care Planning Readiness Scale. This is an 8-item questionnaire that asks questions about patients' readiness to engage in ACP on a 7-point Likert scale (1=Strongly disagree, 7 = Strongly agree). Descriptive statistics will be run, including means and standard deviations for continuous data and frequencies and proportions for categorical data. | At baseline, 6-weeks post-randomization, and 12-weeks post-randomization |
| Self-efficacy for treatment decision-making | Will be measured by the Decision-Making Participation Self-Efficacy (DEPS) scale. The DEPS scale is a 5-item validated measure that assesses cancer patients' confidence in engaging in different activities related to decision-making. Patients are asked to indicate how confident they are that they would be able to engage in various decision-making activities (e.g., "Tell your doctor about the option you would prefer"); items are rated on a 5-point Likert scale (0 = not at all confident, 4 = completely confident). Descriptive statistics will be run, including means and standard deviations for continuous data and frequencies and proportions for categorical data. | At baseline, 6-weeks post-randomization, and 12-weeks post-randomization |
| Psychological distress | Will be measured using the Hospital Anxiety and Depression Scale, a valid and reliable 14-item, Likert-type self-report measure of mood disturbance commonly used with cancer patients. Descriptive statistics will be run, including means and standard deviations for continuous data and frequencies and proportions for categorical data. | At baseline, 6-weeks post-randomization, and 12-weeks post-randomization |
| Prognostic understanding | Will be assessed with items used previously in the team's National Institutes of Health-funded cohort studies of advanced cancer patients and their caregivers: terminal nature of the illness (terminal [accurate] versus non-terminal [inaccurate]) and life-expectancy (months [accurate] versus years [inaccurate]). Descriptive statistics will be run, including means and standard deviations for continuous data and frequencies and proportions for categorical data. | At baseline, 6-weeks post-randomization, and 12-weeks post-randomization |
| Support person [caregiver] burden | Will be measured using the Zarit Burden Interview, a reliable and valid 22-item measure of caregiver burden used in intervention studies of cancer caregivers. Descriptive statistics will be run, including means and standard deviations for continuous data and frequencies and proportions for categorical data. | At baseline, 6-weeks post-randomization, and 12-weeks post-randomization |
| Skagit Regional Health Cancer Care Center | Recruiting | Mount Vernon | Washington | 98274 | United States |
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| Fred Hutch/University of Washington Cancer Consortium | Recruiting | Seattle | Washington | 98109 | United States |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
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