Patient Ambassador Support in Newly Diagnosed Patients With Acute Leukemia During Treatment

NCT03493906 | Completed DMC

• 1 other identifier: Rigshospitalet PAS
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 3

Brief Summary

Background: Acute leukemia is a life threatening hematological malignancy which can result in substantial symptom burden including impaired psychological wellbeing. Peer-to-peer support has positive and beneficial effects on patients with cancer. Yet there is lack of knowledge and evidence of the feasibility and the effect of peer-to-peer support on patient with acute leukemia Aims: The study aim to examine the feasibility and safety of Patient Ambassador Support in newly diagnosed patients with acute leukemia during treatment, and to examine the benefit on symptoms and psychological wellbeing in both patients and ambassadors. Design and methods: This study is a one arm feasibility intervention trial with patients n=40; patient ambassadors (PA) n=30. Patients will be consecutively recruited at the Departments of Hematology, Rigshospitalet, Herlev and Gentofte Hospital and Sjællands Universitetshospital, Roskilde, and paired with a PA who will follow and assist the patient over the course of two series of chemotherapy for a 12 week period, with one follow-up contact at 3 month. Data is collected at baseline (within 2 weeks of diagnosis), post intervention (12 weeks) and follow-up 6 months. Implication: This study has the potential to be a new model for care incorporated in the oncology/hematology clinical care setting, creating an active partnership between patients and former patients; and in collaboration with the health care professionals which may strengthen the existing care and support system.

Conditions

Acute Leukemia

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  Number of participants included from eligible patients

  Up to 2 years

• Adherence to intervention

  number of weeks completed out of planned weeks of intervention

  Up to 24 weeks

• Emotional reactions (Total numbers of contacts with project team members)

  Measured by registration on numbers of contact made by participants to primary investigator / project psychologist / project nurse

  Up to 24 weeks

• Emotional reactions (content of contacts with project team members)

  Measured by registration quality of contact made by participants to primary investigator / project psychologist / project nurse

  Up to 24 weeks

Secondary Outcomes (16)

• Quality Of Life

  Change measures (baseline, 12 weeks, and 24 weeks)

• Symptom burden

  Change measures (baseline, 12 weeks, and 24 weeks)

• Patient Activation Measure

  Change measures (baseline, 12 weeks, and 24 weeks)

• Anxiety and Depression

  Change measures (baseline, 12 weeks, and 24 weeks)

• Quality of Life

  Change measures (baseline, 12 weeks, and 24 weeks)

Study Arms (1)

Intervention

EXPERIMENTAL

Patient Ambassador Support

Other: Patient Ambassador Support

Interventions

Patient Ambassador Support OTHER

Patient Ambassador Support, with former patient treated for acute leukaemia being ambassadors for newly diagnosed patients for a period of 12 weeks.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients are \> 18 years and newly diagnosed with acute leukemia \< 2 weeks of diagnosis who are planned to receive intensive treatment during a course of minimum two series of chemotherapy, and ambassadors (PA) \> 18 years who have completed treatment for their acute leukemia \> 6 month (in complete remission) and provides consent to participate in the ambassador training program, and applicable to all participants (patients and PA) written informed consent is provided.

You may not qualify if:

• Patients and ambassadors are excluded if they do not understand, read and speak Danish, if they have unstable medical disease or cognitive / psychiatric disorders.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (3)

Herlev Hospital

Herlev, 2730, Denmark

Location

Sjællandsuniversitetshospital Roskilde

Roskilde, 4000, Denmark

Location

Rigshospitalet

Copenhagen, Østerbro, 2100, Denmark

Location

Related Publications (2)

• Noerskov KH, Nielsen IH, Rahbaek ES, Halbro S, Mortensen AO, Overgaard UM, Piil K, Jarden M. Implementation and Evaluation of Peer Ambassador Support to Patients Newly Diagnosed With Hematological Cancer and Their Caregivers. Nurs Res Pract. 2025 Apr 28;2025:4528051. doi: 10.1155/nrp/4528051. eCollection 2025.

  PMID: 40330711 DERIVED

• Norskov KH, Overgaard D, Boesen J, Struer A, El-Azem SEWD, Tolver A, Lomborg K, Kjeldsen L, Jarden M. Patient ambassador support in newly diagnosed patients with acute leukemia during treatment: a feasibility study. Support Care Cancer. 2021 Jun;29(6):3077-3089. doi: 10.1007/s00520-020-05819-w. Epub 2020 Oct 13.

  PMID: 33051828 DERIVED

Study Officials

• Mary E Jarden, ph.d.

  Rigshospitalet, Denmark

  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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: April 11, 2018
• Study Start: March 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: March 10, 2021

Record last verified: 2021-03

Locations

DK (3)