NCT07428278

Brief Summary

The aims of this study are to (1) assess the feasibility, acceptability, and usability of the ROCKS intervention among patients with advanced cancer and their family caregivers through a randomized controlled trial in a cancer center setting; (2) evaluate the preliminary efficacy of ROCKS, as compared to usual care, on changes in completion of advance directives; and (3) explore the dyadic effects of resilience on self-efficacy, optimism, dyadic communication and coping, anxiety, and depression using an actor-partner interdependence model.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Mar 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Jul 2028

First Submitted

Initial submission to the registry

February 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

March 20, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

2.2 years

First QC Date

February 16, 2026

Last Update Submit

February 16, 2026

Conditions

Keywords

ResilienceAdvance Care Planning

Outcome Measures

Primary Outcomes (1)

  • Completion of advance directives

    Completion of Five Wishes

    Week 8

Secondary Outcomes (7)

  • Resilience

    Week 8

  • Optimism

    Week 8

  • Dyadic communication and coping

    Week 8

  • Knowledge

    Week 8

  • Self-efficacy

    Week 8

  • +2 more secondary outcomes

Study Arms (2)

ROCKS

EXPERIMENTAL

Participants assigned to this arm will receive a web-based resilience-building intervention.

Behavioral: ROCKS

Usual Care

ACTIVE COMPARATOR

Participants assigned to this arm will receive an advance directive called Five Wishes.

Behavioral: Usual Care

Interventions

ROCKSBEHAVIORAL

The intervention will be provided to participants to strengthen optimism, communication skills, knowledge, and self-efficacy to support patients and family caregivers in engaging in advance care planning discussions.

ROCKS
Usual CareBEHAVIORAL

An advance directive called Five Wishes will be provided to participants to increase their knowledge about advance care planning.

Usual Care

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible patients will (1) be ≥ 18 years of age; (2) be diagnosed with stage 3 or 4 cancer; and (3) have a family caregiver who is willing to participate.
  • Eligible family caregivers will be ≥ 18 years of age. All participants must be able to read, write, and speak English with minimal assistance from others and have access to the internet on a smartphone, laptop, or computer.

You may not qualify if:

  • Patient participants will be ineligible if they have (1) a Short Portable Mental Status Questionnaire (SPMSQ) score \< 8; or (2) have completed any form of advance directive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Li-Ting Longcoy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2026

First Posted

February 23, 2026

Study Start

March 20, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

February 23, 2026

Record last verified: 2026-02