Advanced Malignant Solid NeoplasmNCT07141407
Telephone-Based Coaching Sessions (TAC) to Improve Advance Care Planning Participation in Advanced Cancer Patients and Their Support Person
A study testing Supportive Care, Telephone-Based Intervention and Survey Administration in people with Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm, run by Fred Hutchinson Cancer Center at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
- What is being tested?
- Supportive Care, Telephone-Based Intervention and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Apr 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PATIENT: Current diagnosis of stage III or IV cancer
- PATIENT: Able to provide informed consent
- PATIENT: Fluent in English or Spanish
- PATIENT: Have access to a telephone, computer, or mobile device
- CAREGIVER (SUPPORT PERSON): Person patient indicates provides support
- CAREGIVER (SUPPORT PERSON): English or Spanish speaking
- CAREGIVER (SUPPORT PERSON): 18 years of age or older
- CAREGIVER (SUPPORT PERSON): Able to provide informed consent
Who cannot join
- PATIENT: Too ill or weak to complete the interviews (as judged by the interviewer)
- PATIENT: Receiving hospice at the time of enrollment
- PATIENT: Younger than age 18
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Providence Regional Cancer Partnership
Everett, Washington, 98201
Megan Bannister, MSW, LSWAIC
- Recruiting
Skagit Regional Health Cancer Care Center
Mount Vernon, Washington, 98274
Kiarash Kojouri, MD
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Megan Shen, PhD, 206-667-4172, mshen2@fredhutch.org
Megan Shen, PhD
About this study
Official title: Community-Engaged Pilot Testing of Talking About Cancer (TAC) to Improve Engagement in Advance Care Planning
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.
Read the detailed description
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.
- Being tested
- Supportive Care, Telephone-Based Intervention, Survey Administration, Educational Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Attend TAC telephone-based coaching sessions
Telephone-Based InterventionBehavioural
Attend TAC telephone-based coaching sessions
Survey AdministrationOther
Ancillary studies
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive an ACP brochure/handout
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Supportive Care; Behavioral: Telephone-Based Intervention; Other: Survey Administration |
| Arm II (enhanced usual care) | Active comparator | Participants receive an ACP brochure/handout on study. Receives: Other: Survey Administration; Other: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: At baseline, 6-weeks post- randomization, and 12-weeks post-randomization
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start8 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Shen, PhD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141407
- Sponsor's protocol ID
- RG1125666
- Other IDs
- NCI-2025-05520, FHIRB0020936
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Engaged Pilot Testing of Talking About Cancer (TAC) to Improve Engagement in Advance Care Planning
- ClinicalTrials.gov ID
- NCT07141407
- Acronym / sponsor ID
- RG1125666
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (TAC sessions) | Experimental | Other: Supportive Care, Behavioral: Telephone-Based Intervention, Other: Survey AdministrationParticipants 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 (enhanced usual care) | Active comparator | Other: Survey Administration, Other: Educational InterventionParticipants receive an ACP brochure/handout on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- PATIENT: Current diagnosis of stage III or IV cancer
- PATIENT: Able to provide informed consent
- PATIENT: Fluent in English or Spanish
- PATIENT: Have access to a telephone, computer, or mobile device
- CAREGIVER (SUPPORT PERSON): Person patient indicates provides support
Key exclusion criteria (3 listed)
- PATIENT: Too ill or weak to complete the interviews (as judged by the interviewer)
- PATIENT: Receiving hospice at the time of enrollment
- PATIENT: Younger than age 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveAttend TAC telephone-based coaching sessions | Other | Arm I (TAC sessions) |
| Telephone-Based InterventionAttend TAC telephone-based coaching sessions | Behavioural | Arm I (TAC sessions) |
| Survey AdministrationAncillary studies | Other | Arm I (TAC sessions), Arm II (enhanced usual care) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive an ACP brochure/handout | Other | Arm II (enhanced usual care) |
Primary outcome
Enrollment rate (Feasibility)
Time frame: At 6-weeks post-randomization
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.
Intervention session completion rate (Feasibility)
Time frame: At 6-weeks post-randomization
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.
Acceptability of Intervention Measure (AIM) score (Acceptability)
Time frame: At 6-weeks post-randomization
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).
Completion rate of study assessments (Feasibility of collecting primary and secondary outcomes)
Time frame: At baseline, 6-weeks post- randomization, and 12-weeks post-randomization
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.
11 secondary outcomes
Completion of advance directives
Time frame: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization
Completion of do not resuscitate (DNR) order
Time frame: At baseline, 6-weeks post-randomization, 12-weeks post-randomization
Completion of living will
Time frame: At baseline, 6-weeks post-randomization, and 12-weeks randomization
Identification of a health care proxy
Time frame: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization
Advance care planning (ACP) conversations
Time frame: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization
Level of engagement in ACP
Time frame: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization
Readiness to engage in ACP
Time frame: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization
Self-efficacy for treatment decision-making
Time frame: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization
Psychological distress
Time frame: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization
Prognostic understanding
Time frame: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization
Support person [caregiver] burden
Time frame: At baseline, 6-weeks post-randomization, and 12-weeks post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megan Shen, PhD principal investigator
Fred Hutch/University of Washington Cancer Consortium
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Care, Telephone-Based Intervention and Survey Administration in people with Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm, run by Fred Hutchinson Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Shen, PhD (206-667-4172, mshen2@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (Feasibility) (time frame: At 6-weeks post-randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.