Psycho-Educational Cognition Intervention in Patients With Blood and Lymph Cancer

NCT03804164 | Withdrawn DMC

• 2 other identifiers: 18442NCI-2018-03851
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot trial studies how well a psycho-educational program called Emerging from the Haze works in helping patients with blood and lymph cancer. Sometimes, patients who have undergone treatment for cancer experience thinking or memory problems that make work, school, or everyday life activities, such as grocery shopping, difficult. The Emerging from the Haze program may provide resources to help deal with these types of challenges in patients with blood and lymph cancer.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Outcome Measures

Primary Outcomes (2)

• Enrollment of eligible participants (accrual)

  Feasibility will be assessed through enrollment of \>= 60% of eligible participants (accrual) and completion of at least 5 out of 6 sessions for \>= 80% of participants (adherence/engagement).

  Up to 30 days post the end of the six-week program

• Completion of sessions (adherence/engagement)

  Feasibility will be assessed through enrollment of \>= 60% of eligible participants (accrual) and completion of at least 5 out of 6 sessions for \>= 80% of participants (adherence/engagement).

  Up to 30 days post the end of the six-week program

Secondary Outcomes (5)

• Change in Functional Assessment of Cancer Therapy-Cognition scores

  Baseline up to 30 days post the end of the six-week program

• Change in Patient Reported Outcomes Measurement Information System (PROMIS) scores

  Baseline up to 30 days post the end of the six-week program

• Change in Global Self-Report of Cognition scores

  Baseline up to 30 days post the end of the six-week program

• Change in PROMIS-29 items (29) scores

  Baseline up to 30 days post the end of the six-week program

• Satisfaction Survey scores

  Up to 30 days post the end of the six-week program

Study Arms (1)

Supportive Care (psycho-educational sessions)

EXPERIMENTAL

Patients participate in a psycho-educational program weekly over 2 hours for 6 weeks.

Other: Educational Intervention; Other: Quality-of-Life Assessment; Other: Survey Administration

Interventions

Educational Intervention OTHER

Attend Emerging from the Haze psychoeducational sessions

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Supportive Care (psycho-educational sessions)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive Care (psycho-educational sessions)

Survey Administration OTHER

Ancillary studies

Supportive Care (psycho-educational sessions)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A diagnosis of a hematological malignancy.
• Having received chemotherapy with or without radiation therapy.
• Physician approval.
• Functional Assessment of Cancer Therapy-Cognition (FACT-COG) score \< 59 on the perceived cognitive impairments (PCI) subscale.
• Eligible after 2 months (60 +/- 5 days) of completing all their active cancer treatment with the exception of patients that are post-transplant.
• Subjective complaint of cognitive concerns at time of enrollment.
• Must be able to understand and communicate proficiently in English.
• Ability to understand and the willingness to sign a written informed consent.
• Agree to complete study surveys.

You may not qualify if:

• Patients who have significant personality disorders or unstable psychiatric disorders as assessed by the interviewing clinician.
• Patients with known brain metastases, history of brain metastases or radiation to the brain.
• Patients with a history of stroke or other pre-existing neurological condition that may contribute to cognitive dysfunction.
• Non-English speaking patients.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Natalie Kelly, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 15, 2019
• Study Start: February 10, 2020
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

US (1)